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)

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN

K-Number: K944325 · 1995-02-22

ApplicantPrinceton BioMeditech Corp.
Decision Date1995-02-22
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1995-02-22 under 510(k) number K944325. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN?

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K944325.

When did LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN receive FDA 510(k) clearance?

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN received FDA 510(k) clearance on 1995-02-22, under 510(k) number K944325.

Who is the listed applicant for LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN?

The FDA product code for LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN is JHW.

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 Princeton BioMeditech Corp. 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.

K251538Status™ COVID-19/Flu A&BK182157BioSign Flu A+BK133474BIOSIGN FLU A + B, STATUS FLU A & BK132465BIOSIGN FLU A + B, STATUS FLU A & BK083746BIOSIGN FLU A+BK100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

View all 71 devices →

Related Devices (Code: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, Inc.

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.

↑