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GE Healthcare Finland Oy · Model Pedi-Lite Spirometry Kit 3m, M1032634 · UDI-DI 00840682102858

BZKCCLCBQBZLNHQCBRNHOCAPNHPCBSCCK Prescription
10
510(k) clearances
136
Adverse events (2 deaths)
3
Recalls
38
Facilities

Description

PEDI-LITE+ SPIROMETRY KIT 3M/10FT, M1032634

Recalls

DateFirmReason
2017-12-01Mindray DS USA, Inc. dba Mindray North AmericaThe firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
2011-07-29Respironics Novametrix, LLC.Pressure lines maybe occluded and display incorrect tidal volumes.
2011-07-29Respironics Novametrix, LLC.Pressure lines maybe occluded and display incorrect tidal volumes.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.