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FDA 510(k)

DANNIFLEX MODEL 500TM CPM

K-Number: K904735 · 1991-01-30

ApplicantBuckman Co., Inc.
Decision Date1991-01-30
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DANNIFLEX MODEL 500TM CPM is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K904735. 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 DANNIFLEX MODEL 500TM CPM?

DANNIFLEX MODEL 500TM CPM is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Buckman Co., Inc.. The 510(k) number is K904735.

When did DANNIFLEX MODEL 500TM CPM receive FDA 510(k) clearance?

DANNIFLEX MODEL 500TM CPM received FDA 510(k) clearance on 1991-01-30, under 510(k) number K904735.

Who is the listed applicant for DANNIFLEX MODEL 500TM CPM?

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

What is the FDA product code for DANNIFLEX MODEL 500TM CPM?

The FDA product code for DANNIFLEX MODEL 500TM CPM is BXB.

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Other records listing Buckman Co., Inc. as applicant

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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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