aPROMISE
K-Number: K211655 · 2021-07-27
ApplicantExini Diagnostics AB
Decision Date2021-07-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
aPROMISE is a medical device manufactured by Exini Diagnostics AB. It received FDA 510(k) clearance on 2021-07-27 under approval number K211655. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the aPROMISE?
aPROMISE is a medical device that received FDA 510(k) clearance on 2021-07-27. It is manufactured by Exini Diagnostics AB. The 510(k) number is K211655.
When was aPROMISE approved by the FDA?
aPROMISE received FDA 510(k) clearance on 2021-07-27, under approval number K211655.
What company makes aPROMISE?
aPROMISE is manufactured by Exini Diagnostics AB.
What is the FDA product code for aPROMISE?
The FDA product code for aPROMISE is LLZ.
Other Devices by Exini Diagnostics AB
Related Devices (Code: LLZ)
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.