Ri-Tiniscope-Slit/Ri-Tiniscope Spot/Ri-Vision-Slit/Ri-Vision-Spot

FDA 510(k) K964338 · Rudolf Riester GmbH & Co. KG

Substantially Equivalent

510(k) numberK964338

Submission

Device name
Ri-Tiniscope-Slit/Ri-Tiniscope Spot/Ri-Vision-Slit/Ri-Vision-Spot
Applicant
Rudolf Riester GmbH & Co. KG
D-72417 Jungingen, DE
Received
October 31, 1996
Decision date
January 9, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HKM – Retinoscope, Battery-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.1780
Specialty
Ophthalmic

Other 510(k)s with product code HKM

510(k)DeviceApplicantDecision
K950795Streak Retinoscope Rx-RpHKM · Traditional Neitz Instruments Company, Ltd.03/28/1995SE
K950794Streak Retinoscope Rx-RcHKM · Traditional Neitz Instruments Company, Ltd.03/28/1995SE
K950793Spot Retinoscope RX-3SPHKM · Traditional Neitz Instruments Company, Ltd.03/28/1995SE
K950792Streak Retinoscope RX-3AHKM · Traditional Neitz Instruments Company, Ltd.03/28/1995SE
K950791Streak Retinoscope RX-3HKM · Traditional Neitz Instruments Company, Ltd.03/28/1995SE
K840840Generated Retinal Reflex Imagery SysHKM · Traditional Electro Optical Instruments07/12/1984SE

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Questions and answers

When was Ri-Tiniscope-Slit/Ri-Tiniscope Spot/Ri-Vision-Slit/Ri-Vision-Spot cleared by the FDA?

Ri-Tiniscope-Slit/Ri-Tiniscope Spot/Ri-Vision-Slit/Ri-Vision-Spot (K964338) received a 510(k) decision of Substantially Equivalent on January 9, 1997, 70 days after the submission was received.

What is the product code of K964338?

The FDA product code is HKM – Retinoscope, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.1780.