PROMO
K-Number: K251443 · 2025-08-22
Device Summary
Frequently Asked Questions
What is the PROMO?
PROMO is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is DRGEM Corporation. The 510(k) number is K251443.
When did PROMO receive FDA 510(k) clearance?
PROMO received FDA 510(k) clearance on 2025-08-22, under 510(k) number K251443.
Who is the listed applicant for PROMO?
The FDA 510(k) record lists DRGEM Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROMO?
The FDA product code for PROMO is IZL.
Other records listing DRGEM Corporation as applicant
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.
Related Devices (Code: IZL)
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.
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.