SARNS AIR DETECTION SYSTEM— 510(k) K935977

Name: FDA 510(k) clearance K935977
Creator: U.S. Food and Drug Administration
Published: 1994-02-04

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K935977 for SARNS AIR DETECTION SYSTEM, Substantially Equivalent on 1994-02-04. Applicant: 3M Health Care, Sarns. Device class: 2.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code KRL
Device class: Class 2
Regulation: 21 CFR 870.4205
Advisory panel: Cardiovascular
Date received: 1993-12-13
Decision date: 1994-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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