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FDA 510(k)

DANNIFLEX CPM 600

K-Number: K933394 · 1994-03-11

ApplicantDanninger Medical Technology, Inc.
Decision Date1994-03-11
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DANNIFLEX CPM 600 is the device name listed in this FDA 510(k) record. The listed applicant is Danninger Medical Technology, Inc.. It received FDA 510(k) clearance on 1994-03-11 under 510(k) number K933394. 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 CPM 600?

DANNIFLEX CPM 600 is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Danninger Medical Technology, Inc.. The 510(k) number is K933394.

When did DANNIFLEX CPM 600 receive FDA 510(k) clearance?

DANNIFLEX CPM 600 received FDA 510(k) clearance on 1994-03-11, under 510(k) number K933394.

Who is the listed applicant for DANNIFLEX CPM 600?

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

What is the FDA product code for DANNIFLEX CPM 600?

The FDA product code for DANNIFLEX CPM 600 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.

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 Danninger Medical 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.

K931128BASIC SHOULDER CPMK913026TTU-100THERMAL THERAPY UNITK875223DANNINGER ORTHOPAEDIC AWLK862730DANNIFLEX 400SLK844033MOBILIMB HAND UNIT

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.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.

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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