GBR System
K-Number: K233419 · 2025-01-03
Decision Date2025-01-03
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GBR System is a medical device manufactured by Proimtech Saglik Urunleri Anonim Sirketi. It received FDA 510(k) clearance on 2025-01-03 under approval number K233419. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GBR System?
GBR System is a medical device that received FDA 510(k) clearance on 2025-01-03. It is manufactured by Proimtech Saglik Urunleri Anonim Sirketi. The 510(k) number is K233419.
When was GBR System approved by the FDA?
GBR System received FDA 510(k) clearance on 2025-01-03, under approval number K233419.
What company makes GBR System?
GBR System is manufactured by Proimtech Saglik Urunleri Anonim Sirketi.
What is the FDA product code for GBR System?
The FDA product code for GBR System is DZL.
Other Devices by Proimtech Saglik Urunleri Anonim Sirketi
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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.