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FDA 510(k)

OPTIMAX/ COMPACT 2

K-Number: K992818 · 1999-09-01

ApplicantProtec GmbH & Co. KG
Decision Date1999-09-01
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIMAX/ COMPACT 2 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 1999-09-01 under 510(k) number K992818. 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/ COMPACT 2 is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Protec GmbH & Co. KG. The 510(k) number is K992818.

When did OPTIMAX/ COMPACT 2 receive FDA 510(k) clearance?

OPTIMAX/ COMPACT 2 received FDA 510(k) clearance on 1999-09-01, under 510(k) number K992818.

Who is the listed applicant for OPTIMAX/ COMPACT 2?

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?

The FDA product code for OPTIMAX/ COMPACT 2 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX

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.K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAXProtec GmbH & Co. KGK024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000Daito Co., Ltd.K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.

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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