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FDA 510(k)

ABDOMINAL FETAL ECG MODULE

K-Number: K770245 · 1977-02-14

ApplicantMennen Greatbatch Electonics
Decision Date1977-02-14
Product CodeKXN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ABDOMINAL FETAL ECG MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Greatbatch Electonics. It received FDA 510(k) clearance on 1977-02-14 under 510(k) number K770245. The device is classified under product code KXN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABDOMINAL FETAL ECG MODULE?

ABDOMINAL FETAL ECG MODULE is a medical device that received FDA 510(k) clearance on 1977-02-14. The listed applicant is Mennen Greatbatch Electonics. The 510(k) number is K770245.

When did ABDOMINAL FETAL ECG MODULE receive FDA 510(k) clearance?

ABDOMINAL FETAL ECG MODULE received FDA 510(k) clearance on 1977-02-14, under 510(k) number K770245.

Who is the listed applicant for ABDOMINAL FETAL ECG MODULE?

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

What is the FDA product code for ABDOMINAL FETAL ECG MODULE?

The FDA product code for ABDOMINAL FETAL ECG MODULE is KXN.

Related Clinical Trials

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Other records listing Mennen Greatbatch Electonics 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.

K772000ECG TELEMETRY SYSTEMK770832PORTASCOPE IIK770279MONITOR, PORTABLE, PART #431-010K770247D.C. AMPLIFIER MODULEK770246ISOLATED EEG AMPLIFIER MODULE

Related Devices (Code: KXN)

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.

K760968CENTRAL STATION REPEATER (MODEL 8032A)Hewlett-Packard Co.

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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