EMS MOUTH TO MASK RESUSCITATORS— 510(k) K983919

Substantially Equivalent

Engineered Medical Systems

FDA 510(k) clearance K983919 for EMS MOUTH TO MASK RESUSCITATORS, Substantially Equivalent on 1999-04-07. Applicant: Engineered Medical Systems. Device class: 2.

Clearance details

Applicant
Engineered Medical Systems
Product code
Code CBP
Device class
Class 2
Regulation
21 CFR 868.5870
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
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