OtoSight Middle Ear Scope
K-Number: K222655 · 2022-09-26
ApplicantPhotonicare, Inc.
Decision Date2022-09-26
Product CodeQJG
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OtoSight Middle Ear Scope is a medical device manufactured by Photonicare, Inc.. It received FDA 510(k) clearance on 2022-09-26 under approval number K222655. The device is classified under product code QJG. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OtoSight Middle Ear Scope?
OtoSight Middle Ear Scope is a medical device that received FDA 510(k) clearance on 2022-09-26. It is manufactured by Photonicare, Inc.. The 510(k) number is K222655.
When was OtoSight Middle Ear Scope approved by the FDA?
OtoSight Middle Ear Scope received FDA 510(k) clearance on 2022-09-26, under approval number K222655.
What company makes OtoSight Middle Ear Scope?
OtoSight Middle Ear Scope is manufactured by Photonicare, Inc..
What is the FDA product code for OtoSight Middle Ear Scope?
The FDA product code for OtoSight Middle Ear Scope is QJG.
Other Devices by Photonicare, Inc.
Related Devices (Code: QJG)
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.