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)

OPHTHASONIC A/P III

K-Number: K903666 · 1990-11-19

ApplicantTeknar, Inc.
Decision Date1990-11-19
Product CodeHPY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHASONIC A/P III is the device name listed in this FDA 510(k) record. The listed applicant is Teknar, Inc.. It received FDA 510(k) clearance on 1990-11-19 under 510(k) number K903666. The device is classified under product code HPY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHASONIC A/P III?

OPHTHASONIC A/P III is a medical device that received FDA 510(k) clearance on 1990-11-19. The listed applicant is Teknar, Inc.. The 510(k) number is K903666.

When did OPHTHASONIC A/P III receive FDA 510(k) clearance?

OPHTHASONIC A/P III received FDA 510(k) clearance on 1990-11-19, under 510(k) number K903666.

Who is the listed applicant for OPHTHASONIC A/P III?

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

What is the FDA product code for OPHTHASONIC A/P III?

The FDA product code for OPHTHASONIC A/P III is HPY.

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 Teknar, Inc. 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.

K896038B-SCAN 10 MHZ PROBEK896150IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONICK891777PRO-CUT BIOPSY NEEDLEK883965PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTORK881850TEKNAR PERCU-SCANK881605BIOPSY GUIDE

View all 18 devices →

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.

↑