PROMO
K-Number: K251443 · 2025-08-22
ApplicantDRGEM Corporation
Decision Date2025-08-22
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PROMO is a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2025-08-22 under approval number K251443. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PROMO?
PROMO is a medical device that received FDA 510(k) clearance on 2025-08-22. It is manufactured by DRGEM Corporation. The 510(k) number is K251443.
When was PROMO approved by the FDA?
PROMO received FDA 510(k) clearance on 2025-08-22, under approval number K251443.
What company makes PROMO?
PROMO is manufactured by DRGEM Corporation.
What is the FDA product code for PROMO?
The FDA product code for PROMO is IZL.
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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.