MODEL TI500 ISOLETTE INFANT INCUBATOR— 510(k) K941106

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..

Clearance details

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

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