CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)— 510(k) K964196

Name: FDA 510(k) clearance K964196
Creator: U.S. Food and Drug Administration
Published: 1996-12-23

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K964196 for CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00), Substantially Equivalent on 1996-12-23. Applicant: Northgate Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Northgate Technologies, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-21
Decision date: 1996-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elgin, IL, US

Download summary PDF View on FDA.gov ↗

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