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FDA 510(k)

VOROSCOPE(TM)

K-Number: K871735 · 1987-06-03

ApplicantAustralian Biomedical Corporation , Ltd.
Decision Date1987-06-03
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VOROSCOPE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Australian Biomedical Corporation , Ltd.. It received FDA 510(k) clearance on 1987-06-03 under 510(k) number K871735. 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 VOROSCOPE(TM)?

VOROSCOPE(TM) is a medical device that received FDA 510(k) clearance on 1987-06-03. The listed applicant is Australian Biomedical Corporation , Ltd.. The 510(k) number is K871735.

When did VOROSCOPE(TM) receive FDA 510(k) clearance?

VOROSCOPE(TM) received FDA 510(k) clearance on 1987-06-03, under 510(k) number K871735.

Who is the listed applicant for VOROSCOPE(TM)?

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

What is the FDA product code for VOROSCOPE(TM)?

The FDA product code for VOROSCOPE(TM) 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 Australian Biomedical Corporation , 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.

K862457LYNX EL MICROSCOPY TISSUE PROCESSORK851660DONWAY LIFTING FRAMEK853114ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTORK843522DONWAY SPLINT

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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