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Ventilatory Effort Recorder
FDA product code MNR · Class 2 · Anesthesiology
1,016
Registered devices
126
Adverse events
7
Recalls
165
510(k) clearances
Devices with this code
SOMNOwatch® eco red — SOMNOmedics AGWATCH-PAT 200S-3 — ITAMAR MEDICAL LTDSleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDGrass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDSleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDNatus — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDWithings® — WITHINGSModel 8 — SNAP DIAGNOSTICS LLCEmbla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDNox T3® Demo System with WristOx2 — Nox Medical ehf.Sleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDNight Shift — ADVANCED BRAIN MONITORING, INC.TriplePlay — DYMEDIX DIAGNOSTICS, INC.Xltek — Embla Systems LtdSleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDXltek — Embla Systems LtdAlice NightOne — Respironics, Inc.Sleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDSleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDAlice NightOne — Respironics, Inc.Sleepsense — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDGrass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDAlice PDx — Respironics, Inc.SOMNOtouch RESP accessory — SOMNOmedics AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-07 | NOX MEDICAL | Error in the device firmware results in the inaccurate detection of device position. |
| 2013-04-24 | Embla System Llc | Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could caus |
| 2011-11-11 | Del Mar Reynolds Medical, Ltd. | When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a |
| 2009-12-03 | Ventus Medical, Inc. | The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the oth |
| 2008-05-08 | SagaTech Electronics, Inc. | The outer jacket is receding away from the black sensor prematurely. |
| 2007-10-15 | Respironics, Inc. | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| 2007-10-15 | Respironics, Inc. | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
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