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FDA 510(k)

SENSICARDIAC

K-Number: K121617 · 2012-07-27

ApplicantDiacoustic Medical (Pty)
Decision Date2012-07-27
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSICARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Diacoustic Medical (Pty). It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K121617. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSICARDIAC?

SENSICARDIAC is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Diacoustic Medical (Pty). The 510(k) number is K121617.

When did SENSICARDIAC receive FDA 510(k) clearance?

SENSICARDIAC received FDA 510(k) clearance on 2012-07-27, under 510(k) number K121617.

Who is the listed applicant for SENSICARDIAC?

The FDA 510(k) record lists Diacoustic Medical (Pty) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSICARDIAC?

The FDA product code for SENSICARDIAC is DQD.

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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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