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)

TERUMO FETAL MONITOR # FHM-602

K-Number: K801747 · 1980-08-13

Decision Date1980-08-13
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TERUMO FETAL MONITOR # FHM-602 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801747. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO FETAL MONITOR # FHM-602?

TERUMO FETAL MONITOR # FHM-602 is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Terumo Medical Corp.. The 510(k) number is K801747.

When did TERUMO FETAL MONITOR # FHM-602 receive FDA 510(k) clearance?

TERUMO FETAL MONITOR # FHM-602 received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801747.

Who is the listed applicant for TERUMO FETAL MONITOR # FHM-602?

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

What is the FDA product code for TERUMO FETAL MONITOR # FHM-602?

The FDA product code for TERUMO FETAL MONITOR # FHM-602 is HGM.

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.

Other records listing Terumo Medical 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.

View all 143 devices →

Related Devices (Code: HGM)

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.

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.

↑