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)

LUNEAU STERILE TONOMETER SEPARATION PRISMS

K-Number: K023838 · 2003-02-20

ApplicantLuneau SA
Decision Date2003-02-20
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LUNEAU STERILE TONOMETER SEPARATION PRISMS is the device name listed in this FDA 510(k) record. The listed applicant is Luneau SA. It received FDA 510(k) clearance on 2003-02-20 under 510(k) number K023838. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNEAU STERILE TONOMETER SEPARATION PRISMS?

LUNEAU STERILE TONOMETER SEPARATION PRISMS is a medical device that received FDA 510(k) clearance on 2003-02-20. The listed applicant is Luneau SA. The 510(k) number is K023838.

When did LUNEAU STERILE TONOMETER SEPARATION PRISMS receive FDA 510(k) clearance?

LUNEAU STERILE TONOMETER SEPARATION PRISMS received FDA 510(k) clearance on 2003-02-20, under 510(k) number K023838.

Who is the listed applicant for LUNEAU STERILE TONOMETER SEPARATION PRISMS?

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

What is the FDA product code for LUNEAU STERILE TONOMETER SEPARATION PRISMS?

The FDA product code for LUNEAU STERILE TONOMETER SEPARATION PRISMS is HKY.

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 Luneau SA 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.

K022413LUNEAU 3 MIRROR LENSK851557ANESTHESIOMETER

Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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.

↑