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FDA 510(k)

CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)

K-Number: K964196 · 1996-12-23

ApplicantNorthgate Technologies, Inc.
Decision Date1996-12-23
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1996-12-23 under 510(k) number K964196. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)?

CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K964196.

When did CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) receive FDA 510(k) clearance?

CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) received FDA 510(k) clearance on 1996-12-23, under 510(k) number K964196.

Who is the listed applicant for CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)?

The FDA 510(k) record lists Northgate Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)?

The FDA product code for CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) is OCX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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