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FDA 510(k)

FLEXXR* CPM SYSTEM

K-Number: K834203 · 1984-01-30

ApplicantQarex Laboratories, Inc.
Decision Date1984-01-30
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLEXXR* CPM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Qarex Laboratories, Inc.. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K834203. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXXR* CPM SYSTEM?

FLEXXR* CPM SYSTEM is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Qarex Laboratories, Inc.. The 510(k) number is K834203.

When did FLEXXR* CPM SYSTEM receive FDA 510(k) clearance?

FLEXXR* CPM SYSTEM received FDA 510(k) clearance on 1984-01-30, under 510(k) number K834203.

Who is the listed applicant for FLEXXR* CPM SYSTEM?

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

What is the FDA product code for FLEXXR* CPM SYSTEM?

The FDA product code for FLEXXR* CPM SYSTEM is BXB.

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.

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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