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)

OC3 FLYER

K-Number: K832745 · 1983-09-20

ApplicantIntl. Medical Equipment Corp.
Decision Date1983-09-20
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OC3 FLYER is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Equipment Corp.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832745. 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 OC3 FLYER?

OC3 FLYER is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Intl. Medical Equipment Corp.. The 510(k) number is K832745.

When did OC3 FLYER receive FDA 510(k) clearance?

OC3 FLYER received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832745.

Who is the listed applicant for OC3 FLYER?

The FDA 510(k) record lists Intl. Medical Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OC3 FLYER?

The FDA product code for OC3 FLYER is ITI.

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 Intl. Medical Equipment Corp. 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.

K832321ACCES. HEAD CONTROL-POWERED CHEELCHAIRK832325BASE ONLY, POWER WHEELCHAIRK832322BASE ONLY, TORONTO CHAIRK813104POWER DRIVE WHEELCRK803307MATTRESS, AIR FLOATATION, ALTERN. PRESS.

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.

↑