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FDA 510(k)

FETAL MONITORING SYSTEM

K-Number: K771541 · 1977-08-25

ApplicantAir-Shields, Inc.
Decision Date1977-08-25
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1977-08-25 under 510(k) number K771541. 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 SYSTEM?

FETAL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1977-08-25. The listed applicant is Air-Shields, Inc.. The 510(k) number is K771541.

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

FETAL MONITORING SYSTEM received FDA 510(k) clearance on 1977-08-25, under 510(k) number K771541.

Who is the listed applicant for FETAL MONITORING SYSTEM?

The FDA 510(k) record lists Air-Shields, 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 HGM.

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Other records listing Air-Shields, Inc. as applicant

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K974248WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEMK972309JM-102 JAUNDICE METERK971256DUO-LITE PHOTOTHERAPY SYSTEMK960980ISOLETTE INFANT INCUBATORK924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEK940951RW RESUCITAIRE INFANT RADIANT WARMER

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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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