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FDA 510(k)

RHYTEC, INC., PORTRAIT PSR

K-Number: K082197 · 2008-08-22

ApplicantRhytec Incorporated
Decision Date2008-08-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RHYTEC, INC., PORTRAIT PSR is the device name listed in this FDA 510(k) record. The listed applicant is Rhytec Incorporated. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K082197. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTEC, INC., PORTRAIT PSR?

RHYTEC, INC., PORTRAIT PSR is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Rhytec Incorporated. The 510(k) number is K082197.

When did RHYTEC, INC., PORTRAIT PSR receive FDA 510(k) clearance?

RHYTEC, INC., PORTRAIT PSR received FDA 510(k) clearance on 2008-08-22, under 510(k) number K082197.

Who is the listed applicant for RHYTEC, INC., PORTRAIT PSR?

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

What is the FDA product code for RHYTEC, INC., PORTRAIT PSR?

The FDA product code for RHYTEC, INC., PORTRAIT PSR is GEI.

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Other records listing Rhytec Incorporated 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.

K073111PORTRAIT PSR, MODEL 745915K072394PORTRAIT STAND-OFFK071786PORTRAIT PSRK060948PORTRAIT PSR3

Related Devices (Code: GEI)

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.

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