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FDA 510(k)

FETAL MONITOR #FM-2

K-Number: K832849 · 1983-10-04

ApplicantAdvantage Medical Systems, Inc.
Decision Date1983-10-04
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITOR #FM-2 is the device name listed in this FDA 510(k) record. The listed applicant is Advantage Medical Systems, Inc.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832849. 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 MONITOR #FM-2?

FETAL MONITOR #FM-2 is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Advantage Medical Systems, Inc.. The 510(k) number is K832849.

When did FETAL MONITOR #FM-2 receive FDA 510(k) clearance?

FETAL MONITOR #FM-2 received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832849.

Who is the listed applicant for FETAL MONITOR #FM-2?

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

What is the FDA product code for FETAL MONITOR #FM-2?

The FDA product code for FETAL MONITOR #FM-2 is HGM.

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Other records listing Advantage Medical Systems, Inc. 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.

K873957NON-CORING HUBER TYPE NEEDLESK873290LACERATION AND INSTRUMENT TRAYSK863494NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20K861556MODIFIED FETAL MONITOR MODEL FM-2K861279FLUORO PLUSK861455MODEL DT-102 DATA TELEPHONE TRANSMITTER

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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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