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FDA 510(k)

FM-1000 PLUS FETAL MONITOR

K-Number: K112187 · 2011-09-21

ApplicantAdvanced Instrumentations, Inc.
Decision Date2011-09-21
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FM-1000 PLUS FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2011-09-21 under 510(k) number K112187. 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 FM-1000 PLUS FETAL MONITOR?

FM-1000 PLUS FETAL MONITOR is a medical device that received FDA 510(k) clearance on 2011-09-21. The listed applicant is Advanced Instrumentations, Inc.. The 510(k) number is K112187.

When did FM-1000 PLUS FETAL MONITOR receive FDA 510(k) clearance?

FM-1000 PLUS FETAL MONITOR received FDA 510(k) clearance on 2011-09-21, under 510(k) number K112187.

Who is the listed applicant for FM-1000 PLUS FETAL MONITOR?

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

What is the FDA product code for FM-1000 PLUS FETAL MONITOR?

The FDA product code for FM-1000 PLUS FETAL MONITOR is HGM.

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Other records listing Advanced Instrumentations, Inc. as applicant

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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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