PRIME-XV FreezIS DMSO-Free MD
K-Number: K231804 · 2023-11-09
ApplicantFujifilm Irvine Scientific
Decision Date2023-11-09
Product CodeNDS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PRIME-XV FreezIS DMSO-Free MD is a medical device manufactured by Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2023-11-09 under approval number K231804. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PRIME-XV FreezIS DMSO-Free MD?
PRIME-XV FreezIS DMSO-Free MD is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Fujifilm Irvine Scientific. The 510(k) number is K231804.
When was PRIME-XV FreezIS DMSO-Free MD approved by the FDA?
PRIME-XV FreezIS DMSO-Free MD received FDA 510(k) clearance on 2023-11-09, under approval number K231804.
What company makes PRIME-XV FreezIS DMSO-Free MD?
PRIME-XV FreezIS DMSO-Free MD is manufactured by Fujifilm Irvine Scientific.
What is the FDA product code for PRIME-XV FreezIS DMSO-Free MD?
The FDA product code for PRIME-XV FreezIS DMSO-Free MD is NDS.
Other Devices by Fujifilm Irvine Scientific
Related Devices (Code: NDS)
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.