MODEL TI500 ISOLETTE INFANT INCUBATOR— 510(k) K941106

Name: FDA 510(k) clearance K941106
Creator: U.S. Food and Drug Administration
Published: 1994-06-10

Substantially Equivalent

Air-Shields, Inc.

FDA 510(k) clearance K941106 for MODEL TI500 ISOLETTE INFANT INCUBATOR, Substantially Equivalent on 1994-06-10. Applicant: Air-Shields, Inc.. Device class: 2.

Clearance details

Applicant: Air-Shields, Inc.
Product code: Code FPL
Device class: Class 2
Regulation: 21 CFR 880.5410
Advisory panel: General Hospital
Date received: 1994-03-07
Decision date: 1994-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

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