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FDA 510(k)

FETAL MONITOR, PART #101-11009

K-Number: K770296 · 1977-03-09

ApplicantBrattle Instrument Corp.
Decision Date1977-03-09
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITOR, PART #101-11009 is the device name listed in this FDA 510(k) record. The listed applicant is Brattle Instrument Corp.. It received FDA 510(k) clearance on 1977-03-09 under 510(k) number K770296. 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 FETAL MONITOR, PART #101-11009?

FETAL MONITOR, PART #101-11009 is a medical device that received FDA 510(k) clearance on 1977-03-09. The listed applicant is Brattle Instrument Corp.. The 510(k) number is K770296.

When did FETAL MONITOR, PART #101-11009 receive FDA 510(k) clearance?

FETAL MONITOR, PART #101-11009 received FDA 510(k) clearance on 1977-03-09, under 510(k) number K770296.

Who is the listed applicant for FETAL MONITOR, PART #101-11009?

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

What is the FDA product code for FETAL MONITOR, PART #101-11009?

The FDA product code for FETAL MONITOR, PART #101-11009 is HGM.

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Other records listing Brattle Instrument 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.

K810588SYNCHRONIZER #208K802978TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300K781681PHIPIOLOGICAL SYNCHRONIZER PART#205K770692MONITOR, FETAL, NO. L04-1100K770295ABDOMINAL ECG PROCESSOR FOR FETAL MONI.K770297FETAL MONITOR, PART #100-11009

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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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, 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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