Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OPT80 THE TRANSPORTABLE (OPT80)

K-Number: K972810 · 1997-08-26

ApplicantO.P.T. USA, Inc.
Decision Date1997-08-26
Product CodeFQO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPT80 THE TRANSPORTABLE (OPT80) is the device name listed in this FDA 510(k) record. The listed applicant is O.P.T. USA, Inc.. It received FDA 510(k) clearance on 1997-08-26 under 510(k) number K972810. The device is classified under product code FQO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPT80 THE TRANSPORTABLE (OPT80)?

OPT80 THE TRANSPORTABLE (OPT80) is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is O.P.T. USA, Inc.. The 510(k) number is K972810.

When did OPT80 THE TRANSPORTABLE (OPT80) receive FDA 510(k) clearance?

OPT80 THE TRANSPORTABLE (OPT80) received FDA 510(k) clearance on 1997-08-26, under 510(k) number K972810.

Who is the listed applicant for OPT80 THE TRANSPORTABLE (OPT80)?

The FDA 510(k) record lists O.P.T. USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPT80 THE TRANSPORTABLE (OPT80)?

The FDA product code for OPT80 THE TRANSPORTABLE (OPT80) is FQO.

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

Related Devices (Code: FQO)

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.

K240598Maestro System (REF100)Moon SurgicalK221410Maestro PlatformMoon SurgicalK090136STERIS CMAX XLT SURGICAL TABLESTERIS CorporationK971988ALLEN, ULTRA AND SMART SOCKETSAllen Medical Systems, Inc.K971307AMSCO SURGICAL TABLESTERIS CorporationK963506TENET RADIOLUCENT HAND TABLETenet Medical Engineering

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.

↑