MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION— 510(k) K991955

Name: FDA 510(k) clearance K991955
Creator: U.S. Food and Drug Administration
Published: 1999-07-06

Substantially Equivalent

Engineered Medical Systems

FDA 510(k) clearance K991955 for MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION, Substantially Equivalent on 1999-07-06. Applicant: Engineered Medical Systems. Device class: 2.

Clearance details

Applicant: Engineered Medical Systems
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1999-06-01
Decision date: 1999-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.