DEMISTIFIER ISOLATION CHAMBER— 510(k) K902161

Name: FDA 510(k) clearance K902161
Creator: U.S. Food and Drug Administration
Published: 1990-10-15

Substantially Equivalent

Peace Medical, Inc.

FDA 510(k) clearance K902161 for DEMISTIFIER ISOLATION CHAMBER, Substantially Equivalent on 1990-10-15. Applicant: Peace Medical, Inc.. Device class: 2.

Clearance details

Applicant: Peace Medical, Inc.
Product code: Code CBN
Device class: Class 2
Regulation: 21 CFR 868.5430
Advisory panel: Anesthesiology
Date received: 1990-05-15
Decision date: 1990-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, NJ, US

Download summary PDF View on FDA.gov ↗

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