MERCURY MEDICAL REUSABLE CPR BAG— 510(k) K970756

Substantially Equivalent

Mercury Medical

FDA 510(k) clearance K970756 for MERCURY MEDICAL REUSABLE CPR BAG, Substantially Equivalent on 1997-10-31. Applicant: Mercury Medical.

Clearance details

Applicant: Mercury Medical
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1997-03-03
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.