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FDA 510(k)

PROWESS PANTHER PROARC, MODEL VERSION 5.0

K-Number: K101076 · 2010-07-27

ApplicantProwess, Inc.
Decision Date2010-07-27
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROWESS PANTHER PROARC, MODEL VERSION 5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2010-07-27 under 510(k) number K101076. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROWESS PANTHER PROARC, MODEL VERSION 5.0?

PROWESS PANTHER PROARC, MODEL VERSION 5.0 is a medical device that received FDA 510(k) clearance on 2010-07-27. The listed applicant is Prowess, Inc.. The 510(k) number is K101076.

When did PROWESS PANTHER PROARC, MODEL VERSION 5.0 receive FDA 510(k) clearance?

PROWESS PANTHER PROARC, MODEL VERSION 5.0 received FDA 510(k) clearance on 2010-07-27, under 510(k) number K101076.

Who is the listed applicant for PROWESS PANTHER PROARC, MODEL VERSION 5.0?

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 PROWESS PANTHER PROARC, MODEL VERSION 5.0?

The FDA product code for PROWESS PANTHER PROARC, MODEL VERSION 5.0 is MUJ.

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Other records listing Prowess, Inc. as applicant

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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.

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