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FDA 510(k)

EDTA CAVIT

K-Number: K970246 · 1997-04-16

ApplicantKarolinski
Decision Date1997-04-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EDTA CAVIT is the device name listed in this FDA 510(k) record. The listed applicant is Karolinski. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K970246. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDTA CAVIT?

EDTA CAVIT is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Karolinski. The 510(k) number is K970246.

When did EDTA CAVIT receive FDA 510(k) clearance?

EDTA CAVIT received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970246.

Who is the listed applicant for EDTA CAVIT?

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

What is the FDA product code for EDTA CAVIT?

The FDA product code for EDTA CAVIT is EBF.

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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