IMMOBILE STERILE AND IMMOBILE A/C STERILE— 510(k) K941940

Substantially Equivalent

Tnt Moborg Intl. , Ltd.

FDA 510(k) clearance K941940 for IMMOBILE STERILE AND IMMOBILE A/C STERILE, Substantially Equivalent on 1994-07-14. Applicant: Tnt Moborg Intl. , Ltd..

Clearance details

Applicant: Tnt Moborg Intl. , Ltd.
Product code: Code KMK
Advisory panel: General Hospital
Date received: 1994-04-21
Decision date: 1994-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.