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FDA 510(k)

MODIFIED FETAL MONITOR MODEL FM-2

K-Number: K861556 · 1986-07-07

ApplicantAdvantage Medical Systems, Inc.
Decision Date1986-07-07
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFIED FETAL MONITOR MODEL 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 1986-07-07 under 510(k) number K861556. 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 MODIFIED FETAL MONITOR MODEL FM-2?

MODIFIED FETAL MONITOR MODEL FM-2 is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Advantage Medical Systems, Inc.. The 510(k) number is K861556.

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

MODIFIED FETAL MONITOR MODEL FM-2 received FDA 510(k) clearance on 1986-07-07, under 510(k) number K861556.

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

The FDA product code for MODIFIED FETAL MONITOR MODEL 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 20K861279FLUORO PLUSK861455MODEL DT-102 DATA TELEPHONE TRANSMITTERK852518MODIFICATION FETAL MONITOR MODEL FM-2

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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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