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FDA 510(k)

Panther OIS

K-Number: K211760 · 2021-09-28

ApplicantProwess, Inc.
Decision Date2021-09-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Panther OIS is a medical device manufactured by Prowess, Inc.. It received FDA 510(k) clearance on 2021-09-28 under approval number K211760. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther OIS?

Panther OIS is a medical device that received FDA 510(k) clearance on 2021-09-28. It is manufactured by Prowess, Inc.. The 510(k) number is K211760.

When was Panther OIS approved by the FDA?

Panther OIS received FDA 510(k) clearance on 2021-09-28, under approval number K211760.

What company makes Panther OIS?

Panther OIS is manufactured by Prowess, Inc..

What is the FDA product code for Panther OIS?

The FDA product code for Panther OIS is IYE.

Other Devices by Prowess, Inc.

K193459Panther Stereotactic K231825Panther TPS

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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.

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