OHMEDA INFANT RESUSCITATION SYSTEM— 510(k) K971243

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K971243 for OHMEDA INFANT RESUSCITATION SYSTEM, Substantially Equivalent on 1997-12-02. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1997-04-03
Decision date: 1997-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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.