MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR— 510(k) K954866

Name: FDA 510(k) clearance K954866
Creator: U.S. Food and Drug Administration
Published: 1996-01-30

Substantially Equivalent

Mercury Medical

FDA 510(k) clearance K954866 for MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR, Substantially Equivalent on 1996-01-30. Applicant: Mercury Medical. Device class: 2.

Clearance details

Applicant: Mercury Medical
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1995-10-24
Decision date: 1996-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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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.