TYPE INTERFACE 9271/1 INCUBATOR/WARMER— 510(k) K912000

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K912000 for TYPE INTERFACE 9271/1 INCUBATOR/WARMER, Substantially Equivalent on 1992-09-21. Applicant: S & W Medico Teknik.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1991-04-24
Decision date: 1992-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.