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FDA 510(k)

CRYOPRO MAXI AND CRYOPRO MINI

K-Number: K982280 · 1998-11-25

ApplicantCortex Technology Aps
Decision Date1998-11-25
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOPRO MAXI AND CRYOPRO MINI is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Technology Aps. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K982280. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOPRO MAXI AND CRYOPRO MINI?

CRYOPRO MAXI AND CRYOPRO MINI is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Cortex Technology Aps. The 510(k) number is K982280.

When did CRYOPRO MAXI AND CRYOPRO MINI receive FDA 510(k) clearance?

CRYOPRO MAXI AND CRYOPRO MINI received FDA 510(k) clearance on 1998-11-25, under 510(k) number K982280.

Who is the listed applicant for CRYOPRO MAXI AND CRYOPRO MINI?

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

What is the FDA product code for CRYOPRO MAXI AND CRYOPRO MINI?

The FDA product code for CRYOPRO MAXI AND CRYOPRO MINI is GEH.

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Other records listing Cortex Technology Aps as applicant

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.

K983945CORTEX DERMASCAN C ULTRASONIC SYSTEM

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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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