Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DANTEC COUNTERPOINT MK2(TM)

K-Number: K913957 · 1992-01-30

ApplicantDantec Medical, Inc.
Decision Date1992-01-30
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DANTEC COUNTERPOINT MK2(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K913957. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANTEC COUNTERPOINT MK2(TM)?

DANTEC COUNTERPOINT MK2(TM) is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K913957.

When did DANTEC COUNTERPOINT MK2(TM) receive FDA 510(k) clearance?

DANTEC COUNTERPOINT MK2(TM) received FDA 510(k) clearance on 1992-01-30, under 510(k) number K913957.

Who is the listed applicant for DANTEC COUNTERPOINT MK2(TM)?

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

What is the FDA product code for DANTEC COUNTERPOINT MK2(TM)?

The FDA product code for DANTEC COUNTERPOINT MK2(TM) is GWJ.

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 Dantec Medical, 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.

K960503DANTEC DUETK950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)K953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP L

View all 25 devices →

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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.

↑