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FDA 510(k)

HEINE BETA 200(R) OPHTHALMOSCOPE

K-Number: K131961 · 2013-12-04

ApplicantHeine Optotechnik GmbH & Co. KG
Decision Date2013-12-04
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEINE BETA 200(R) OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Heine Optotechnik GmbH & Co. KG. It received FDA 510(k) clearance on 2013-12-04 under 510(k) number K131961. 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 HEINE BETA 200(R) OPHTHALMOSCOPE?

HEINE BETA 200(R) OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is Heine Optotechnik GmbH & Co. KG. The 510(k) number is K131961.

When did HEINE BETA 200(R) OPHTHALMOSCOPE receive FDA 510(k) clearance?

HEINE BETA 200(R) OPHTHALMOSCOPE received FDA 510(k) clearance on 2013-12-04, under 510(k) number K131961.

Who is the listed applicant for HEINE BETA 200(R) OPHTHALMOSCOPE?

The FDA 510(k) record lists Heine Optotechnik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEINE BETA 200(R) OPHTHALMOSCOPE?

The FDA product code for HEINE BETA 200(R) 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 Heine Optotechnik GmbH & Co. KG 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.

K123587HEINE MINI 3000 LED OPHTHALMOSCOPEK123316HEINE OMEGA 500K101892HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-

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.

K131719OPHTHALMOSCOPES 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.K061278OPTYSE OPHTHALMOSCOPEOphthalmos , Ltd.

Official Source

View on FDA Database →

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

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