FDA 510(k)

RSCRIBE ELECTROCARDIOGRAPH

K-Number: K120865 · 2012-07-19

Decision Date2012-07-19

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RSCRIBE ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2012-07-19 under 510(k) number K120865. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSCRIBE ELECTROCARDIOGRAPH?

RSCRIBE ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 2012-07-19. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K120865.

When did RSCRIBE ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

RSCRIBE ELECTROCARDIOGRAPH received FDA 510(k) clearance on 2012-07-19, under 510(k) number K120865.

Who is the listed applicant for RSCRIBE ELECTROCARDIOGRAPH?

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

What is the FDA product code for RSCRIBE ELECTROCARDIOGRAPH?

The FDA product code for RSCRIBE ELECTROCARDIOGRAPH is DPS.

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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.