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FDA 510(k)

M2100 ANTEPARTUM FETAL MONITOR

K-Number: K823081 · 1983-01-26

ApplicantHuntleigh Technology, Inc.
Decision Date1983-01-26
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

M2100 ANTEPARTUM FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Technology, Inc.. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K823081. 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 M2100 ANTEPARTUM FETAL MONITOR?

M2100 ANTEPARTUM FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Huntleigh Technology, Inc.. The 510(k) number is K823081.

When did M2100 ANTEPARTUM FETAL MONITOR receive FDA 510(k) clearance?

M2100 ANTEPARTUM FETAL MONITOR received FDA 510(k) clearance on 1983-01-26, under 510(k) number K823081.

Who is the listed applicant for M2100 ANTEPARTUM FETAL MONITOR?

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

What is the FDA product code for M2100 ANTEPARTUM FETAL MONITOR?

The FDA product code for M2100 ANTEPARTUM FETAL MONITOR is HGM.

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Other records listing Huntleigh Technology, 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.

K992733AKRON ATP9 TRACTION MACHINEK964699RHEO DOPPLEX II (RD 2)K924516OP3/VP4K910188FLOWPLUS AC330 PUMP GARMENTSK900882MULTI DOPPLEX, MD-1K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140

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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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