HUNTLEIGH FP5000 SYSTEM MODEL FP5000— 510(k) K965153

Name: FDA 510(k) clearance K965153
Creator: U.S. Food and Drug Administration
Published: 1998-01-26

Substantially Equivalent

Huntleigh Healthcare, Inc.

FDA 510(k) clearance K965153 for HUNTLEIGH FP5000 SYSTEM MODEL FP5000, Substantially Equivalent on 1998-01-26. Applicant: Huntleigh Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: Huntleigh Healthcare, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1996-12-23
Decision date: 1998-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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