FDA 510(k)

TOMi Scope

K-Number: K191804 · 2019-12-05

Decision Date2019-12-05

Product CodeQJG

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TOMi 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 2019-12-05 under 510(k) number K191804. 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 TOMi Scope?

TOMi Scope is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Photonicare, Inc.. The 510(k) number is K191804.

When did TOMi Scope receive FDA 510(k) clearance?

TOMi Scope received FDA 510(k) clearance on 2019-12-05, under 510(k) number K191804.

Who is the listed applicant for TOMi 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 TOMi Scope?

The FDA product code for TOMi 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.

K222655OtoSight Middle Ear Scope

Related Devices (Code: QJG)

K222655OtoSight Middle Ear 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.