BTL-899
K-Number: K192224 · 2019-12-05
ApplicantBtl
Decision Date2019-12-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BTL-899 is a medical device manufactured by Btl. It received FDA 510(k) clearance on 2019-12-05 under approval number K192224. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BTL-899?
BTL-899 is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Btl. The 510(k) number is K192224.
When was BTL-899 approved by the FDA?
BTL-899 received FDA 510(k) clearance on 2019-12-05, under approval number K192224.
What company makes BTL-899?
BTL-899 is manufactured by Btl.
What is the FDA product code for BTL-899?
The FDA product code for BTL-899 is GEI.
Other Devices by Btl
Related Devices (Code: GEI)
K161307NICO MyriadNico Corporation
K163190InMode RF SystemInmode MD , Ltd.
K163373PK AIMGyrus Acmi, Inc.
K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL
K162676Voyant Open Fusion DeviceApplied Medical Resources
K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien
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.