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Standard Starter Set

SenTec AG · Model SSET · UDI-DI 07640121880094

LPPKLKDQADPZLKD Prescription
2
510(k) clearances
10
Adverse events
1
Recalls
13
Facilities

Description

Standard Starter Set contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer tool (reloadable) (MC-R) Contact Gel (GEL-04) Service Gas (GAS-0812)

Recalls

DateFirmReason
2012-11-27Radiometer America IncRADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.