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FDA 510(k)

FETAL MONITORING SYSTEM

K-Number: K780487 · 1978-05-09

ApplicantSonicaid, Inc.
Decision Date1978-05-09
Product CodeHFO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sonicaid, Inc.. It received FDA 510(k) clearance on 1978-05-09 under 510(k) number K780487. The device is classified under product code HFO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETAL MONITORING SYSTEM?

FETAL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1978-05-09. The listed applicant is Sonicaid, Inc.. The 510(k) number is K780487.

When did FETAL MONITORING SYSTEM receive FDA 510(k) clearance?

FETAL MONITORING SYSTEM received FDA 510(k) clearance on 1978-05-09, under 510(k) number K780487.

Who is the listed applicant for FETAL MONITORING SYSTEM?

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

What is the FDA product code for FETAL MONITORING SYSTEM?

The FDA product code for FETAL MONITORING SYSTEM is HFO.

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Other records listing Sonicaid, Inc. as applicant

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Related Devices (Code: HFO)

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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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