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FDA 510(k)

PRESSURE INFUSION CUFF

K-Number: K942933 · 1994-08-25

ApplicantCirculatory Technology, Inc.
Decision Date1994-08-25
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSURE INFUSION CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Circulatory Technology, Inc.. It received FDA 510(k) clearance on 1994-08-25 under 510(k) number K942933. The device is classified under product code KZD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE INFUSION CUFF?

PRESSURE INFUSION CUFF is a medical device that received FDA 510(k) clearance on 1994-08-25. The listed applicant is Circulatory Technology, Inc.. The 510(k) number is K942933.

When did PRESSURE INFUSION CUFF receive FDA 510(k) clearance?

PRESSURE INFUSION CUFF received FDA 510(k) clearance on 1994-08-25, under 510(k) number K942933.

Who is the listed applicant for PRESSURE INFUSION CUFF?

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

What is the FDA product code for PRESSURE INFUSION CUFF?

The FDA product code for PRESSURE INFUSION CUFF is KZD.

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Other records listing Circulatory Technology, 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.

K012942THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500K001822THE V-BAGK981284BETTER-BLADDER (BB)K964205BETTER-TUBINGK964337BETTER-BLADDER (BB)K961594BETTER-VENTER

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Related Devices (Code: KZD)

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.

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K973843MSI PRESSURE INFUSORSmith Assoc.K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.K951988PRESSURIZERPromedic, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, Inc.

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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