AMBU RESUSCITATOR— 510(k) K771350

Substantially Equivalent

Air-Shields, Inc.

FDA 510(k) clearance K771350 for AMBU RESUSCITATOR, Substantially Equivalent on 1977-08-19. Applicant: Air-Shields, Inc..

Clearance details

Applicant: Air-Shields, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1977-07-21
Decision date: 1977-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.