REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)— 510(k) K980235

Name: FDA 510(k) clearance K980235
Creator: U.S. Food and Drug Administration
Published: 1998-04-09

Substantially Equivalent

Kci New Technologies, Inc.

FDA 510(k) clearance K980235 for REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR), Substantially Equivalent on 1998-04-09. Applicant: Kci New Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kci New Technologies, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1998-01-22
Decision date: 1998-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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