Synaptive ImageDrive Pro
K-Number: K153284 · 2016-03-29
ApplicantSynaptive Medical, Inc.
Decision Date2016-03-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Synaptive ImageDrive Pro is a medical device manufactured by Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2016-03-29 under approval number K153284. 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 Synaptive ImageDrive Pro?
Synaptive ImageDrive Pro is a medical device that received FDA 510(k) clearance on 2016-03-29. It is manufactured by Synaptive Medical, Inc.. The 510(k) number is K153284.
When was Synaptive ImageDrive Pro approved by the FDA?
Synaptive ImageDrive Pro received FDA 510(k) clearance on 2016-03-29, under approval number K153284.
What company makes Synaptive ImageDrive Pro?
Synaptive ImageDrive Pro is manufactured by Synaptive Medical, Inc..
What is the FDA product code for Synaptive ImageDrive Pro?
The FDA product code for Synaptive ImageDrive Pro 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.