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FDA 510(k)

POCKET OPHTHALMOSCOPE GH

K-Number: K843897 · 1984-11-27

ApplicantDesign Med. Corp.
Decision Date1984-11-27
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

POCKET OPHTHALMOSCOPE GH is the device name listed in this FDA 510(k) record. The listed applicant is Design Med. Corp.. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K843897. 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 POCKET OPHTHALMOSCOPE GH?

POCKET OPHTHALMOSCOPE GH is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Design Med. Corp.. The 510(k) number is K843897.

When did POCKET OPHTHALMOSCOPE GH receive FDA 510(k) clearance?

POCKET OPHTHALMOSCOPE GH received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843897.

Who is the listed applicant for POCKET OPHTHALMOSCOPE GH?

The FDA 510(k) record lists Design Med. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POCKET OPHTHALMOSCOPE GH?

The FDA product code for POCKET OPHTHALMOSCOPE GH is HLJ.

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Other records listing Design Med. Corp. 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.

K852953#SM-3001 OPHTHA OTOSC SET SUBSETS SOLDK852334MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)

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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