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FDA 510(k)

PANTHER REALART, MODEL 4.7

K-Number: K083502 · 2009-05-05

ApplicantProwess, Inc.
Decision Date2009-05-05
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PANTHER REALART, MODEL 4.7 is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2009-05-05 under 510(k) number K083502. 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 PANTHER REALART, MODEL 4.7?

PANTHER REALART, MODEL 4.7 is a medical device that received FDA 510(k) clearance on 2009-05-05. The listed applicant is Prowess, Inc.. The 510(k) number is K083502.

When did PANTHER REALART, MODEL 4.7 receive FDA 510(k) clearance?

PANTHER REALART, MODEL 4.7 received FDA 510(k) clearance on 2009-05-05, under 510(k) number K083502.

Who is the listed applicant for PANTHER REALART, MODEL 4.7?

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 REALART, MODEL 4.7?

The FDA product code for PANTHER REALART, MODEL 4.7 is MUJ.

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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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Related Devices (Code: MUJ)

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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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