FDA 510(k)

Panther OIS

K-Number: K211760 · 2021-09-28

Decision Date2021-09-28

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Panther OIS is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) 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. The listed applicant is Prowess, Inc.. The 510(k) number is K211760.

When did Panther OIS receive FDA 510(k) clearance?

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

Who is the listed applicant for Panther OIS?

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

What is the FDA product code for Panther OIS?

The FDA product code for Panther OIS is IYE.

Other records listing Prowess, 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.

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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.