Next Generation iBOT
K-Number: K172601 · 2018-03-02
ApplicantDeka Research & Development Corp.
Decision Date2018-03-02
Product CodeIMK
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Next Generation iBOT is a medical device manufactured by Deka Research & Development Corp.. It received FDA 510(k) clearance on 2018-03-02 under approval number K172601. The device is classified under product code IMK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Next Generation iBOT?
Next Generation iBOT is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Deka Research & Development Corp.. The 510(k) number is K172601.
When was Next Generation iBOT approved by the FDA?
Next Generation iBOT received FDA 510(k) clearance on 2018-03-02, under approval number K172601.
What company makes Next Generation iBOT?
Next Generation iBOT is manufactured by Deka Research & Development Corp..
What is the FDA product code for Next Generation iBOT?
The FDA product code for Next Generation iBOT is IMK.
Other Devices by Deka Research & Development Corp.
Related Devices (Code: IMK)
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.