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)

US SENSOR #CG-930P; TOCO SENSOR CG-940P

K-Number: K003876 · 2001-07-09

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2001-07-09
Product CodeHEL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

US SENSOR #CG-930P; TOCO SENSOR CG-940P is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K003876. The device is classified under product code HEL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the US SENSOR #CG-930P; TOCO SENSOR CG-940P?

US SENSOR #CG-930P; TOCO SENSOR CG-940P is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K003876.

When did US SENSOR #CG-930P; TOCO SENSOR CG-940P receive FDA 510(k) clearance?

US SENSOR #CG-930P; TOCO SENSOR CG-940P received FDA 510(k) clearance on 2001-07-09, under 510(k) number K003876.

Who is the listed applicant for US SENSOR #CG-930P; TOCO SENSOR CG-940P?

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

What is the FDA product code for US SENSOR #CG-930P; TOCO SENSOR CG-940P?

The FDA product code for US SENSOR #CG-930P; TOCO SENSOR CG-940P is HEL.

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 Card Guard Scientific Survival , 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.

K111745KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDERK110499CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORK101703MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084K101639CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTORK083174HEALTHEPODK082521EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM

View all 49 devices →

Related Devices (Code: HEL)

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.

K010920TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGMedical Cables, Inc.K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCorometrics Medical Systems, Inc.K971240ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006Alexander Mfg. Co.K930714SONICAID MODEL TEAM FECG IUPOxford Instruments, Plc.K933816SONICAID MODEL P110 FETAL HEAR DETECTOROxford Instruments, Plc.K780035MINIVISORMetrix Teknika, 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.

↑