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FDA 510(k)

TESTOK-125

K-Number: K800776 · 1980-04-21

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1980-04-21
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TESTOK-125 is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1980-04-21 under 510(k) number K800776. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESTOK-125?

TESTOK-125 is a medical device that received FDA 510(k) clearance on 1980-04-21. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K800776.

When did TESTOK-125 receive FDA 510(k) clearance?

TESTOK-125 received FDA 510(k) clearance on 1980-04-21, under 510(k) number K800776.

Who is the listed applicant for TESTOK-125?

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

What is the FDA product code for TESTOK-125?

The FDA product code for TESTOK-125 is CDZ.

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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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