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FDA 510(k)

PUMA MODEL VERSION 1.0

K-Number: K100801 · 2010-06-18

ApplicantProwess, Inc.
Decision Date2010-06-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PUMA MODEL VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2010-06-18 under 510(k) number K100801. 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 PUMA MODEL VERSION 1.0?

PUMA MODEL VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2010-06-18. The listed applicant is Prowess, Inc.. The 510(k) number is K100801.

When did PUMA MODEL VERSION 1.0 receive FDA 510(k) clearance?

PUMA MODEL VERSION 1.0 received FDA 510(k) clearance on 2010-06-18, under 510(k) number K100801.

Who is the listed applicant for PUMA MODEL VERSION 1.0?

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 PUMA MODEL VERSION 1.0?

The FDA product code for PUMA MODEL VERSION 1.0 is IYE.

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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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