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FDA 510(k)

PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112

K-Number: K063735 · 2007-09-19

ApplicantPresym, Inc.
Decision Date2007-09-19
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 is the device name listed in this FDA 510(k) record. The listed applicant is Presym, Inc.. It received FDA 510(k) clearance on 2007-09-19 under 510(k) number K063735. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112?

PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 is a medical device that received FDA 510(k) clearance on 2007-09-19. The listed applicant is Presym, Inc.. The 510(k) number is K063735.

When did PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 receive FDA 510(k) clearance?

PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 received FDA 510(k) clearance on 2007-09-19, under 510(k) number K063735.

Who is the listed applicant for PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112?

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

What is the FDA product code for PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112?

The FDA product code for PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 is DRT.

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Related Devices (Code: DRT)

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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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