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FDA 510(k)

DANNIFLEX 400SL

K-Number: K862730 · 1986-07-24

ApplicantDanninger Medical Technology, Inc.
Decision Date1986-07-24
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DANNIFLEX 400SL 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 1986-07-24 under 510(k) number K862730. 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 400SL?

DANNIFLEX 400SL is a medical device that received FDA 510(k) clearance on 1986-07-24. The listed applicant is Danninger Medical Technology, Inc.. The 510(k) number is K862730.

When did DANNIFLEX 400SL receive FDA 510(k) clearance?

DANNIFLEX 400SL received FDA 510(k) clearance on 1986-07-24, under 510(k) number K862730.

Who is the listed applicant for DANNIFLEX 400SL?

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 400SL?

The FDA product code for DANNIFLEX 400SL 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 CPMK933394DANNIFLEX CPM 600K913026TTU-100THERMAL THERAPY UNITK875223DANNINGER ORTHOPAEDIC AWLK844033MOBILIMB 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.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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