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TC electrode
Radiometer Medical ApS · Model 904-308 · UDI-DI 05700699043085
LPP
Prescription
2
510(k) clearances
10
Adverse events
1
Recalls
13
Facilities
Description
D826 Accessory kit for TC pO2 electrode
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-11-27 | Radiometer America Inc | RADIOMETER 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.
Get your free API keyRead the docsData 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.