BrightMatter Plan 1.6.0
K-Number: K180394 · 2018-03-09
ApplicantSynaptive Medical, Inc.
Decision Date2018-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BrightMatter Plan 1.6.0 is a medical device manufactured by Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2018-03-09 under approval number K180394. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BrightMatter Plan 1.6.0?
BrightMatter Plan 1.6.0 is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Synaptive Medical, Inc.. The 510(k) number is K180394.
When was BrightMatter Plan 1.6.0 approved by the FDA?
BrightMatter Plan 1.6.0 received FDA 510(k) clearance on 2018-03-09, under approval number K180394.
What company makes BrightMatter Plan 1.6.0?
BrightMatter Plan 1.6.0 is manufactured by Synaptive Medical, Inc..
What is the FDA product code for BrightMatter Plan 1.6.0?
The FDA product code for BrightMatter Plan 1.6.0 is LLZ.
Other Devices by Synaptive Medical, Inc.
Related Devices (Code: LLZ)
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.