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FDA 510(k)

RI-SCOPE S OTOSCOPE

K-Number: K945640 · 1995-01-17

ApplicantRudolf Riester GmbH & Co. KG
Decision Date1995-01-17
Product CodeHLJ
Advisory CommitteeOP
DecisionUnknown

Device Summary

RI-SCOPE S OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH & Co. KG. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K945640. The device is classified under product code HLJ. It was reviewed by the OP advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the RI-SCOPE S OTOSCOPE?

RI-SCOPE S OTOSCOPE is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K945640.

When did RI-SCOPE S OTOSCOPE receive FDA 510(k) clearance?

RI-SCOPE S OTOSCOPE received FDA 510(k) clearance on 1995-01-17, under 510(k) number K945640.

Who is the listed applicant for RI-SCOPE S OTOSCOPE?

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

What is the FDA product code for RI-SCOPE S OTOSCOPE?

The FDA product code for RI-SCOPE S OTOSCOPE is HLJ.

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Other records listing Rudolf Riester 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.

K002954RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERSK002955EMPIRE N BLOOD PRESSURE MANOMETERSK972377RI-MEGAK972378SANAPHON NK972379PRECISA NK972301BIG BEN SQUARE, BIG BEN ROUND

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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

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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