Klarity SRS Baseplate, Klarity Promise Baseplate
K-Number: K220539 · 2022-11-01
Decision Date2022-11-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Klarity SRS Baseplate, Klarity Promise Baseplate is a medical device manufactured by Klarity Medical & Equipment (GZ) Co., Ltd.. It received FDA 510(k) clearance on 2022-11-01 under approval number K220539. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Klarity SRS Baseplate, Klarity Promise Baseplate?
Klarity SRS Baseplate, Klarity Promise Baseplate is a medical device that received FDA 510(k) clearance on 2022-11-01. It is manufactured by Klarity Medical & Equipment (GZ) Co., Ltd.. The 510(k) number is K220539.
When was Klarity SRS Baseplate, Klarity Promise Baseplate approved by the FDA?
Klarity SRS Baseplate, Klarity Promise Baseplate received FDA 510(k) clearance on 2022-11-01, under approval number K220539.
What company makes Klarity SRS Baseplate, Klarity Promise Baseplate?
Klarity SRS Baseplate, Klarity Promise Baseplate is manufactured by Klarity Medical & Equipment (GZ) Co., Ltd..
What is the FDA product code for Klarity SRS Baseplate, Klarity Promise Baseplate?
The FDA product code for Klarity SRS Baseplate, Klarity Promise Baseplate is IYE.
Other Devices by Klarity Medical & Equipment (GZ) Co., Ltd.
Related Devices (Code: IYE)
K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc.
K161400ImagingRing SystemMedphoton GmbH
K162468ClearCheckRadformation
K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV
K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC
K162265CushionCast Moldable CushionsIzi Medical Products, LLC
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.