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FDA 510(k)

OPTIMA

K-Number: K913222 · 1991-12-20

ApplicantOlympic Controls Corp.
Decision Date1991-12-20
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIMA is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Controls Corp.. It received FDA 510(k) clearance on 1991-12-20 under 510(k) number K913222. The device is classified under product code IZO. It was reviewed by the RA 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 1991-12-20. The listed applicant is Olympic Controls Corp.. The 510(k) number is K913222.

When did OPTIMA receive FDA 510(k) clearance?

OPTIMA received FDA 510(k) clearance on 1991-12-20, under 510(k) number K913222.

Who is the listed applicant for OPTIMA?

The FDA 510(k) record lists Olympic Controls Corp. 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 IZO.

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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Related PubMed Literature

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.

PMID: 30005090Straight-Line Vector Planning for Optimal Results With Silhouette InstaLift in Minimally Invasive Tissue Repositioning for Facial Rejuvenation.Journal of drugs in dermatology : JDD ()

Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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