FDA 510(k)

OtoSight Middle Ear Scope

K-Number: K222655 · 2022-09-26

Decision Date2022-09-26

Product CodeQJG

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OtoSight Middle Ear Scope is the device name listed in this FDA 510(k) record. The listed applicant is Photonicare, Inc.. It received FDA 510(k) clearance on 2022-09-26 under 510(k) 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. The listed applicant is Photonicare, Inc.. The 510(k) number is K222655.

When did OtoSight Middle Ear Scope receive FDA 510(k) clearance?

OtoSight Middle Ear Scope received FDA 510(k) clearance on 2022-09-26, under 510(k) number K222655.

Who is the listed applicant for OtoSight Middle Ear Scope?

The FDA 510(k) record lists Photonicare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OtoSight Middle Ear Scope?

The FDA product code for OtoSight Middle Ear Scope is QJG.

Other records listing Photonicare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191804TOMi Scope

Related Devices (Code: QJG)

K191804TOMi ScopePhotonicare, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.