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FDA 510(k)

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER

K-Number: K021574 · 2002-08-12

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2002-08-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2002-08-12 under 510(k) number K021574. 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 TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER?

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER is a medical device that received FDA 510(k) clearance on 2002-08-12. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K021574.

When did TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER receive FDA 510(k) clearance?

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER received FDA 510(k) clearance on 2002-08-12, under 510(k) number K021574.

Who is the listed applicant for TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER?

The FDA product code for TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER is HGM.

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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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