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FDA 510(k)

PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015

K-Number: K043092 · 2004-12-13

ApplicantProgeny, Inc.
Decision Date2004-12-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 is the device name listed in this FDA 510(k) record. The listed applicant is Progeny, Inc.. It received FDA 510(k) clearance on 2004-12-13 under 510(k) number K043092. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015?

PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 is a medical device that received FDA 510(k) clearance on 2004-12-13. The listed applicant is Progeny, Inc.. The 510(k) number is K043092.

When did PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 receive FDA 510(k) clearance?

PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 received FDA 510(k) clearance on 2004-12-13, under 510(k) number K043092.

Who is the listed applicant for PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015?

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

What is the FDA product code for PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015?

The FDA product code for PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 is EHD.

Related Clinical Trials

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.

Other records listing Progeny, 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.

Related Devices (Code: EHD)

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.

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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