SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE— 510(k) K924709

Name: FDA 510(k) clearance K924709
Creator: U.S. Food and Drug Administration
Published: 1996-01-17

Substantially Equivalent

Air-Shields, Inc.

FDA 510(k) clearance K924709 for SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE, Substantially Equivalent on 1996-01-17. Applicant: Air-Shields, Inc.. Device class: 2.

Clearance details

Applicant: Air-Shields, Inc.
Product code: Code KLK
Device class: Class 2
Regulation: 21 CFR 868.2500
Advisory panel: Anesthesiology
Date received: 1992-09-18
Decision date: 1996-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

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