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 a medical device manufactured by Nuance Medical, LLC. It received FDA 510(k) clearance on 2021-10-22 under approval 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. It is manufactured by Nuance Medical, LLC. The 510(k) number is K210310.
When was CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit approved by the FDA?
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit received FDA 510(k) clearance on 2021-10-22, under approval number K210310.
What company makes 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 manufactured by Nuance Medical, LLC.
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 Devices by Nuance Medical, LLC
Related Devices (Code: GEH)
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.