RESPOSABLE INFANT RESUSCITATOR— 510(k) K961882

Substantially Equivalent

Medical Marketing Concepts

FDA 510(k) clearance K961882 for RESPOSABLE INFANT RESUSCITATOR, Substantially Equivalent on 1996-06-28. Applicant: Medical Marketing Concepts.

Clearance details

Applicant: Medical Marketing Concepts
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1996-05-15
Decision date: 1996-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, VA, 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.