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)

BIRTHTRACK (A.K.A. CLM)

K-Number: K082704 · 2009-01-09

ApplicantBarnev, Ltd.
Decision Date2009-01-09
Product CodeNPB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIRTHTRACK (A.K.A. CLM) is the device name listed in this FDA 510(k) record. The listed applicant is Barnev, Ltd.. It received FDA 510(k) clearance on 2009-01-09 under 510(k) number K082704. The device is classified under product code NPB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIRTHTRACK (A.K.A. CLM)?

BIRTHTRACK (A.K.A. CLM) is a medical device that received FDA 510(k) clearance on 2009-01-09. The listed applicant is Barnev, Ltd.. The 510(k) number is K082704.

When did BIRTHTRACK (A.K.A. CLM) receive FDA 510(k) clearance?

BIRTHTRACK (A.K.A. CLM) received FDA 510(k) clearance on 2009-01-09, under 510(k) number K082704.

Who is the listed applicant for BIRTHTRACK (A.K.A. CLM)?

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

What is the FDA product code for BIRTHTRACK (A.K.A. CLM)?

The FDA product code for BIRTHTRACK (A.K.A. CLM) is NPB.

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 Barnev, Ltd. 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.

K080672BIRTHTRACK

Related Devices (Code: NPB)

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.

K081984LABORPRO SYSTEMTrig Medical, Ltd.K080672BIRTHTRACKBarnev, Ltd.

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.

↑