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FDA 510(k)

RODENSTOCK SLITLAMP (MODEL 5000 & 4000)

K-Number: K962532 · 1996-07-25

ApplicantExpertech Assoc., Inc.
Decision Date1996-07-25
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RODENSTOCK SLITLAMP (MODEL 5000 & 4000) is the device name listed in this FDA 510(k) record. The listed applicant is Expertech Assoc., Inc.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K962532. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RODENSTOCK SLITLAMP (MODEL 5000 & 4000)?

RODENSTOCK SLITLAMP (MODEL 5000 & 4000) is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Expertech Assoc., Inc.. The 510(k) number is K962532.

When did RODENSTOCK SLITLAMP (MODEL 5000 & 4000) receive FDA 510(k) clearance?

RODENSTOCK SLITLAMP (MODEL 5000 & 4000) received FDA 510(k) clearance on 1996-07-25, under 510(k) number K962532.

Who is the listed applicant for RODENSTOCK SLITLAMP (MODEL 5000 & 4000)?

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

What is the FDA product code for RODENSTOCK SLITLAMP (MODEL 5000 & 4000)?

The FDA product code for RODENSTOCK SLITLAMP (MODEL 5000 & 4000) is HJO.

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 Expertech Assoc., 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.

K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER

Related Devices (Code: HJO)

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.

K262637SLIT LAMP SL-D4 (Type: LED)Topcon CorporationK253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument 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.

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