LIFEGUARD MOUTH TO MASK RESUSCITATOR— 510(k) K881086

Substantially Equivalent

Lifeguard Medical Products, Inc.

FDA 510(k) clearance K881086 for LIFEGUARD MOUTH TO MASK RESUSCITATOR, Substantially Equivalent on 1988-04-14. Applicant: Lifeguard Medical Products, Inc..

Clearance details

Applicant: Lifeguard Medical Products, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1988-03-14
Decision date: 1988-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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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.