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FDA 510(k)

MONITOR, FETAL HEART, MODEL 1980

K-Number: K770292 · 1977-03-09

ApplicantBerkeley Bio-Engineering
Decision Date1977-03-09
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MONITOR, FETAL HEART, MODEL 1980 is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Bio-Engineering. It received FDA 510(k) clearance on 1977-03-09 under 510(k) number K770292. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, FETAL HEART, MODEL 1980?

MONITOR, FETAL HEART, MODEL 1980 is a medical device that received FDA 510(k) clearance on 1977-03-09. The listed applicant is Berkeley Bio-Engineering. The 510(k) number is K770292.

When did MONITOR, FETAL HEART, MODEL 1980 receive FDA 510(k) clearance?

MONITOR, FETAL HEART, MODEL 1980 received FDA 510(k) clearance on 1977-03-09, under 510(k) number K770292.

Who is the listed applicant for MONITOR, FETAL HEART, MODEL 1980?

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

What is the FDA product code for MONITOR, FETAL HEART, MODEL 1980?

The FDA product code for MONITOR, FETAL HEART, MODEL 1980 is HGI.

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Other records listing Berkeley Bio-Engineering 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.

K790645ENDOTOMEK771711BIOTOMEK771644FRAGMATOME MODEL 820

Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, 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.

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