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FDA 510(k)

FETAL MONITORING SYS. MODEL FM3R

K-Number: K771379 · 1977-08-03

ApplicantSonicaid, Inc.
Decision Date1977-08-03
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITORING SYS. MODEL FM3R is the device name listed in this FDA 510(k) record. The listed applicant is Sonicaid, Inc.. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771379. 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 MONITORING SYS. MODEL FM3R?

FETAL MONITORING SYS. MODEL FM3R is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Sonicaid, Inc.. The 510(k) number is K771379.

When did FETAL MONITORING SYS. MODEL FM3R receive FDA 510(k) clearance?

FETAL MONITORING SYS. MODEL FM3R received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771379.

Who is the listed applicant for FETAL MONITORING SYS. MODEL FM3R?

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 SYS. MODEL FM3R?

The FDA product code for FETAL MONITORING SYS. MODEL FM3R is HGM.

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Other records listing Sonicaid, Inc. as applicant

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K873673BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONALK8720745 MHZ TRANSDUCERK863803VASOPULSE(TM)/MODEL 5000K862720VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBESK861237VASOVIEW DUPLEX IMAGING SYSTEMK851102VASOSCREEN IMPEDANCE PLETHYSMOGRAPH

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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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