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FDA 510(k)

CREST PRESSURE INFUSOR

K-Number: K822434 · 1982-09-17

ApplicantCrest Medical Equipment
Decision Date1982-09-17
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CREST PRESSURE INFUSOR is the device name listed in this FDA 510(k) record. The listed applicant is Crest Medical Equipment. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822434. 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 CREST PRESSURE INFUSOR?

CREST PRESSURE INFUSOR is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Crest Medical Equipment. The 510(k) number is K822434.

When did CREST PRESSURE INFUSOR receive FDA 510(k) clearance?

CREST PRESSURE INFUSOR received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822434.

Who is the listed applicant for CREST PRESSURE INFUSOR?

The FDA 510(k) record lists Crest Medical Equipment as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREST PRESSURE INFUSOR?

The FDA product code for CREST PRESSURE INFUSOR is KZD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Crest Medical Equipment 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.

K790810DISPOSA-CUF

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.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.

Official Source

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

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