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FDA 510(k)

KOWA SC-1200 PHOTO SLIT LAMP SYSTEM

K-Number: K955442 · 1996-01-03

ApplicantKowa Optimed, Inc.
Decision Date1996-01-03
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA SC-1200 PHOTO SLIT LAMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Optimed, Inc.. It received FDA 510(k) clearance on 1996-01-03 under 510(k) number K955442. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA SC-1200 PHOTO SLIT LAMP SYSTEM?

KOWA SC-1200 PHOTO SLIT LAMP SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-03. The listed applicant is Kowa Optimed, Inc.. The 510(k) number is K955442.

When did KOWA SC-1200 PHOTO SLIT LAMP SYSTEM receive FDA 510(k) clearance?

KOWA SC-1200 PHOTO SLIT LAMP SYSTEM received FDA 510(k) clearance on 1996-01-03, under 510(k) number K955442.

Who is the listed applicant for KOWA SC-1200 PHOTO SLIT LAMP SYSTEM?

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

What is the FDA product code for KOWA SC-1200 PHOTO SLIT LAMP SYSTEM?

The FDA product code for KOWA SC-1200 PHOTO SLIT LAMP SYSTEM is HKI.

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Other records listing Kowa Optimed, 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.

K013805KOWA AUTOMATED TONOMETER KT-500K961090AUTOMATIC VISUAL FIELD PLOTTER AP-125K960924KOWA HAND-HELD APPLANATION TONOMETER HA-1K954780KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500CK954781KOWA GENESIS HAND-HELD FUNDUS CAMERAK954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14B

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Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, 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.

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