THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS— 510(k) K964939

Name: FDA 510(k) clearance K964939
Creator: U.S. Food and Drug Administration
Published: 1997-03-06

Substantially Equivalent

Creative Biomedics, Inc.

FDA 510(k) clearance K964939 for THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS, Substantially Equivalent on 1997-03-06. Applicant: Creative Biomedics, Inc.. Device class: 2.

Clearance details

Applicant: Creative Biomedics, Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1996-12-10
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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