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)

HEALTHPHONE TOCO MODEL

K-Number: K874631 · 1988-03-11

ApplicantCarelink
Decision Date1988-03-11
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HEALTHPHONE TOCO MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Carelink. It received FDA 510(k) clearance on 1988-03-11 under 510(k) number K874631. The device is classified under product code HFM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHPHONE TOCO MODEL?

HEALTHPHONE TOCO MODEL is a medical device that received FDA 510(k) clearance on 1988-03-11. The listed applicant is Carelink. The 510(k) number is K874631.

When did HEALTHPHONE TOCO MODEL receive FDA 510(k) clearance?

HEALTHPHONE TOCO MODEL received FDA 510(k) clearance on 1988-03-11, under 510(k) number K874631.

Who is the listed applicant for HEALTHPHONE TOCO MODEL?

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

What is the FDA product code for HEALTHPHONE TOCO MODEL?

The FDA product code for HEALTHPHONE TOCO MODEL is HFM.

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 Carelink 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.

K862668HEALTHPHONE(TM)

Related Devices (Code: HFM)

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.

K061044FEATHERLITE AQUA TOCODYNAMOMETERVentrex, Inc.K040392TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGAmerican I.V. Products, Inc.K013477TOCO LITE, MODEL TD-01Ventrex, Inc.K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565Precision Dynamics Corp.K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGEpic Medical Equipment Services, Inc.K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, 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.

↑