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FDA 510(k)

D.L. SCOPE OPHTHALMOSCOPE

K-Number: K896072 · 1989-11-27

ApplicantNorth American Medical Products, Inc.
Decision Date1989-11-27
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

D.L. SCOPE OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is North American Medical Products, Inc.. It received FDA 510(k) clearance on 1989-11-27 under 510(k) number K896072. 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 D.L. SCOPE OPHTHALMOSCOPE?

D.L. SCOPE OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1989-11-27. The listed applicant is North American Medical Products, Inc.. The 510(k) number is K896072.

When did D.L. SCOPE OPHTHALMOSCOPE receive FDA 510(k) clearance?

D.L. SCOPE OPHTHALMOSCOPE received FDA 510(k) clearance on 1989-11-27, under 510(k) number K896072.

Who is the listed applicant for D.L. SCOPE OPHTHALMOSCOPE?

The FDA 510(k) record lists North American Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D.L. SCOPE OPHTHALMOSCOPE?

The FDA product code for D.L. SCOPE OPHTHALMOSCOPE is HLJ.

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 North American Medical Products, 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.

K001965SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMSK905305SAFE-SITE NEEDLE COVERK895948PORT-O-SCOPE(TM)K862661D.L. SCOPE(R) OTOSCOPEK841778D.L. SCOPE BLADE & HANDLE

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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