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FDA 510(k)

TAPE-A-TRACE

K-Number: K791892 · 1979-11-05

ApplicantInstromedix, Inc.
Decision Date1979-11-05
Product CodeDXM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TAPE-A-TRACE is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791892. The device is classified under product code DXM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAPE-A-TRACE?

TAPE-A-TRACE is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Instromedix, Inc.. The 510(k) number is K791892.

When did TAPE-A-TRACE receive FDA 510(k) clearance?

TAPE-A-TRACE received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791892.

Who is the listed applicant for TAPE-A-TRACE?

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

What is the FDA product code for TAPE-A-TRACE?

The FDA product code for TAPE-A-TRACE is DXM.

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Other records listing Instromedix, Inc. as applicant

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K964408POSEIDON CARDIAC MONITORING SYSTEM (PCMS)K964036CARDIOMAGIC 2000 SOFTWAREK955060ACCELERATED TRANSMISSION PROTOCOLK951096LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVERK945476HEARTHWATCH III(TM)K950003CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS

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Related Devices (Code: DXM)

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.

K781692CALIBRATOR, DYNAMICWaters Assoc., 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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