Medical Device Manufacturer · DE , Hamburg

Heine Optotechnik GmbH & Co. KG - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2010

7

Total

7

Cleared

0

Denied

Heine Optotechnik GmbH & Co. KG — FDA 510(k) Products and Clearance History Ophthalmic ✕

6 devices

1-6 of 6

Cleared May 18, 2015

HEINE BETA 200, HEINE BETA 200 S, HEINE K 180

Ophthalmic · 256d

Cleared Jan 29, 2015

HEINE SIGMA 250 & HEINE SIGMA 250 M2

Ophthalmic · 121d

Cleared Mar 07, 2014

HEINE MINI 3000(R) OPHTHALMOSCOPE

Ophthalmic · 253d

Cleared Dec 04, 2013

HEINE BETA 200(R) OPHTHALMOSCOPE

Ophthalmic · 160d

Cleared Mar 22, 2013

HEINE MINI 3000 LED OPHTHALMOSCOPE

Ophthalmic · 121d

Cleared Feb 26, 2013

HEINE OMEGA 500

Ophthalmic · 124d