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FDA 510(k)

THERMO SCIENTIFIC MAS OMNI-CARDIO

K-Number: K122291 · 2012-08-31

ApplicantMicrogenics Corporation
Decision Date2012-08-31
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC MAS OMNI-CARDIO is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2012-08-31 under 510(k) number K122291. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC MAS OMNI-CARDIO?

THERMO SCIENTIFIC MAS OMNI-CARDIO is a medical device that received FDA 510(k) clearance on 2012-08-31. The listed applicant is Microgenics Corporation. The 510(k) number is K122291.

When did THERMO SCIENTIFIC MAS OMNI-CARDIO receive FDA 510(k) clearance?

THERMO SCIENTIFIC MAS OMNI-CARDIO received FDA 510(k) clearance on 2012-08-31, under 510(k) number K122291.

Who is the listed applicant for THERMO SCIENTIFIC MAS OMNI-CARDIO?

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

What is the FDA product code for THERMO SCIENTIFIC MAS OMNI-CARDIO?

The FDA product code for THERMO SCIENTIFIC MAS OMNI-CARDIO is JJY.

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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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