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FDA 510(k)

FETALERT ADR FETAL MONITOR

K-Number: K871383 · 1987-06-01

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1987-06-01
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETALERT ADR FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1987-06-01 under 510(k) number K871383. 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 FETALERT ADR FETAL MONITOR?

FETALERT ADR FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1987-06-01. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K871383.

When did FETALERT ADR FETAL MONITOR receive FDA 510(k) clearance?

FETALERT ADR FETAL MONITOR received FDA 510(k) clearance on 1987-06-01, under 510(k) number K871383.

Who is the listed applicant for FETALERT ADR FETAL MONITOR?

The FDA 510(k) record lists Advanced Technology Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FETALERT ADR FETAL MONITOR?

The FDA product code for FETALERT ADR FETAL MONITOR is HGM.

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Related Devices (Code: HGM)

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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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