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FDA 510(k)

OPTIMA

K-Number: K011053 · 2001-04-20

ApplicantMedical Industries America, Inc.
Decision Date2001-04-20
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OPTIMA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Industries America, Inc.. It received FDA 510(k) clearance on 2001-04-20 under 510(k) number K011053. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMA?

OPTIMA is a medical device that received FDA 510(k) clearance on 2001-04-20. The listed applicant is Medical Industries America, Inc.. The 510(k) number is K011053.

When did OPTIMA receive FDA 510(k) clearance?

OPTIMA received FDA 510(k) clearance on 2001-04-20, under 510(k) number K011053.

Who is the listed applicant for OPTIMA?

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

What is the FDA product code for OPTIMA?

The FDA product code for OPTIMA is ITI.

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Related PubMed Literature

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Other records listing Medical Industries America, Inc. as applicant

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K050990REMREST HEATED HUMIDIFIERK032170TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000K002763REMRESTK9640783050 SPORT-NEBK9439903000 AEROSOL TWOK9424443002 AEROMAX

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Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

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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