EMERGENCY OXYGEN RESUSCITATOR— 510(k) K771299

Substantially Equivalent

Fraser Sweatman, Inc.

FDA 510(k) clearance K771299 for EMERGENCY OXYGEN RESUSCITATOR, Substantially Equivalent on 1977-08-04. Applicant: Fraser Sweatman, Inc..

Clearance details

Applicant: Fraser Sweatman, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1977-07-14
Decision date: 1977-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.