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FDA 510(k)

MODEL 2100 FETAL MONITOR

K-Number: K837102 · 1983-03-14

ApplicantHuntleigh Group , Ltd.
Decision Date1983-03-14
Product Code
DecisionSubstantially Equivalent

Device Summary

MODEL 2100 FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Group , Ltd.. It received FDA 510(k) clearance on 1983-03-14 under 510(k) number K837102. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 2100 FETAL MONITOR?

MODEL 2100 FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1983-03-14. The listed applicant is Huntleigh Group , Ltd.. The 510(k) number is K837102.

When did MODEL 2100 FETAL MONITOR receive FDA 510(k) clearance?

MODEL 2100 FETAL MONITOR received FDA 510(k) clearance on 1983-03-14, under 510(k) number K837102.

Who is the listed applicant for MODEL 2100 FETAL MONITOR?

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

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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