OXYGEN POWERED RESUSCITATOR FOR CPR— 510(k) K920910

Substantially Equivalent

J. H. Emerson Co.

FDA 510(k) clearance K920910 for OXYGEN POWERED RESUSCITATOR FOR CPR, Substantially Equivalent on 1993-01-12. Applicant: J. H. Emerson Co..

Clearance details

Applicant: J. H. Emerson Co.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1992-02-27
Decision date: 1993-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.