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)

OCULAB BIOMETRICPEN

K-Number: K860061 · 1986-03-10

ApplicantOculab, Inc.
Decision Date1986-03-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OCULAB BIOMETRICPEN is the device name listed in this FDA 510(k) record. The listed applicant is Oculab, Inc.. It received FDA 510(k) clearance on 1986-03-10 under 510(k) number K860061. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULAB BIOMETRICPEN?

OCULAB BIOMETRICPEN is a medical device that received FDA 510(k) clearance on 1986-03-10. The listed applicant is Oculab, Inc.. The 510(k) number is K860061.

When did OCULAB BIOMETRICPEN receive FDA 510(k) clearance?

OCULAB BIOMETRICPEN received FDA 510(k) clearance on 1986-03-10, under 510(k) number K860061.

Who is the listed applicant for OCULAB BIOMETRICPEN?

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

What is the FDA product code for OCULAB BIOMETRICPEN?

The FDA product code for OCULAB BIOMETRICPEN is IYO.

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 Oculab, 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.

K884619PACH-PEN CALCULATORK882750OCU-FILM TIP COVERK862016PACH-PEN SURGICAL DRAPEK860205BIO-PEN CALCULATORK860062OCULAB PACHPENK852774OCULAB TONOPEN

View all 7 devices →

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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.

↑