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FDA 510(k)

SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500

K-Number: K093639 · 2009-12-03

ApplicantHuvitz Co., Ltd.
Decision Date2009-12-03
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 is the device name listed in this FDA 510(k) record. The listed applicant is Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2009-12-03 under 510(k) number K093639. 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 SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500?

SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 is a medical device that received FDA 510(k) clearance on 2009-12-03. The listed applicant is Huvitz Co., Ltd.. The 510(k) number is K093639.

When did SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 receive FDA 510(k) clearance?

SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 received FDA 510(k) clearance on 2009-12-03, under 510(k) number K093639.

Who is the listed applicant for SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500?

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

What is the FDA product code for SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500?

The FDA product code for SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 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.

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Other records listing Huvitz Co., Ltd. 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.

K232143Applanation Tonometer HT-5000K202097Fundus CameraK191615Huvitz Imaging SystemK161829Huvitz Imaging SystemK073190SLIT LAMP

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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