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FDA 510(k)

MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)

K-Number: K852334 · 1985-06-18

ApplicantDesign Med. Corp.
Decision Date1985-06-18
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) 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 1985-06-18 under 510(k) number K852334. 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 MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)?

MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) is a medical device that received FDA 510(k) clearance on 1985-06-18. The listed applicant is Design Med. Corp.. The 510(k) number is K852334.

When did MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) receive FDA 510(k) clearance?

MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) received FDA 510(k) clearance on 1985-06-18, under 510(k) number K852334.

Who is the listed applicant for MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)?

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 MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)?

The FDA product code for MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) 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 SOLDK843897POCKET OPHTHALMOSCOPE GH

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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