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FDA 510(k)

OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX

K-Number: K091628 · 2009-08-21

ApplicantProtec GmbH & Co. KG
Decision Date2009-08-21
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX is the device name listed in this FDA 510(k) record. The listed applicant is Protec GmbH & Co. KG. It received FDA 510(k) clearance on 2009-08-21 under 510(k) number K091628. The device is classified under product code IXW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX?

OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX is a medical device that received FDA 510(k) clearance on 2009-08-21. The listed applicant is Protec GmbH & Co. KG. The 510(k) number is K091628.

When did OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX receive FDA 510(k) clearance?

OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX received FDA 510(k) clearance on 2009-08-21, under 510(k) number K091628.

Who is the listed applicant for OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX?

The FDA 510(k) record lists Protec GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX?

The FDA product code for OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX is IXW.

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.

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Other records listing Protec GmbH & Co. KG 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.

K992818OPTIMAX/ COMPACT 2

Related Devices (Code: IXW)

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.

K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINTVelopex International, Inc.K093503INTRAX FILM PROCESSORVelopex International, Inc.K024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000Daito Co., Ltd.K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.K023613AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036Alphatek Corp.

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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