SIMS HYPERINFLATION BAG SYSTEM— 510(k) K970785

Substantially Equivalent

Sims

FDA 510(k) clearance K970785 for SIMS HYPERINFLATION BAG SYSTEM, Substantially Equivalent on 1997-06-13. Applicant: Sims. Device class: 2.

Clearance details

Applicant: Sims
Product code: Code NHK
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 1997-03-04
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

Download summary PDF View on FDA.gov ↗

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