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FDA 510(k)

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit

K-Number: K210310 · 2021-10-22

ApplicantNuance Medical, LLC
Decision Date2021-10-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K210310. 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 CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Nuance Medical, LLC. The 510(k) number is K210310.

When did CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit receive FDA 510(k) clearance?

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit received FDA 510(k) clearance on 2021-10-22, under 510(k) number K210310.

Who is the listed applicant for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

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

What is the FDA product code for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

The FDA product code for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is GEH.

Other records listing Nuance Medical, LLC as applicant

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Related Devices (Code: GEH)

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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