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FDA 510(k)

HUNTLEIGH FP5000 SYSTEM MODEL FP5000

K-Number: K965153 · 1998-01-26

ApplicantHuntleigh Healthcare, Inc.
Decision Date1998-01-26
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HUNTLEIGH FP5000 SYSTEM MODEL FP5000 is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 1998-01-26 under 510(k) number K965153. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUNTLEIGH FP5000 SYSTEM MODEL FP5000?

HUNTLEIGH FP5000 SYSTEM MODEL FP5000 is a medical device that received FDA 510(k) clearance on 1998-01-26. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K965153.

When did HUNTLEIGH FP5000 SYSTEM MODEL FP5000 receive FDA 510(k) clearance?

HUNTLEIGH FP5000 SYSTEM MODEL FP5000 received FDA 510(k) clearance on 1998-01-26, under 510(k) number K965153.

Who is the listed applicant for HUNTLEIGH FP5000 SYSTEM MODEL FP5000?

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

What is the FDA product code for HUNTLEIGH FP5000 SYSTEM MODEL FP5000?

The FDA product code for HUNTLEIGH FP5000 SYSTEM MODEL FP5000 is JOW.

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Other records listing Huntleigh Healthcare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032315IOP8 INTRA OPERATIVE PROBEK022786DVT60K010744FLOWTRON UNIVERSAL, MODEL AC600K012008STS RANGE , MODELS STS20,STS30,STS40K002186VASCULAR ASSISTK010894BABY DOPPLEX 3002 (BD3002)

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Related Devices (Code: JOW)

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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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