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FDA 510(k)

ORIEL

K-Number: K920272 · 1992-07-09

ApplicantTruphatek, Ltd.
Decision Date1992-07-09
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORIEL is the device name listed in this FDA 510(k) record. The listed applicant is Truphatek, Ltd.. It received FDA 510(k) clearance on 1992-07-09 under 510(k) number K920272. The device is classified under product code HLJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIEL?

ORIEL is a medical device that received FDA 510(k) clearance on 1992-07-09. The listed applicant is Truphatek, Ltd.. The 510(k) number is K920272.

When did ORIEL receive FDA 510(k) clearance?

ORIEL received FDA 510(k) clearance on 1992-07-09, under 510(k) number K920272.

Who is the listed applicant for ORIEL?

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

What is the FDA product code for ORIEL?

The FDA product code for ORIEL is HLJ.

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Other records listing Truphatek, 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.

K923227THROAT-A-SCOPEK902205OTOSCOPEK883414LARYNGOSCOPE BLADES

Related Devices (Code: HLJ)

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.

K131961HEINE BETA 200(R) OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK131719OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITSMedical Devices (Pvt) , Ltd.K123587HEINE MINI 3000 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSAmerican Diagnostic Corp.K070270PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36Kirchner & Wilhelm GmbH + Co.KgK05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25ASuzhou 66 Vision Tech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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