HKM · Class I · 21 CFR 886.1780

FDA Product Code HKM: Retinoscope, Battery-powered

Leading manufacturers include Neitz Instruments Company, Ltd. and Rudolf Riester GmbH & Co. KG.

7
Total
7
Cleared
55d
Avg days
1984
Since

FDA 510(k) Cleared Retinoscope, Battery-powered Devices (Product Code HKM)

7 devices
1–7 of 7
Cleared Jan 09, 1997
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
K964338
Rudolf Riester GmbH & Co. KG
Ophthalmic · 70d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-3
K950791
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-3A
K950792
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
SPOT RETINOSCOPE RX-3SP
K950793
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-RC
K950794
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-RP
K950795
Neitz Instruments Company, Ltd.
Ophthalmic · 35d

About Product Code HKM - Regulatory Context