Medical Device Manufacturer · DE , Hamburg

Heine Optotechnik GmbH & Co. KG

7 submissions · 7 cleared · Since 2010

Total

Cleared

Denied

Heine Optotechnik GmbH & Co. KG — FDA 510(k) Submissions

Heine Optotechnik GmbH & Co. KG has submitted 7 FDA 510(k) premarket notifications since 2010, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ophthalmoscope, Battery-powered, Blood Pressure Cuff, Ophthalmoscope, Ac-powered . Use the specialty filter in the sidebar to narrow results.

7 devices

1–7 of 7

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

K142486 · HLJ Ophthalmoscope,... · Ophthalmic

May 2015 256d

HEINE SIGMA 250 & HEINE SIGMA 250 M2

K142837 · HLJ Ophthalmoscope,... · Ophthalmic

Jan 2015 121d

HEINE MINI 3000(R) OPHTHALMOSCOPE

K131959 · HLJ Ophthalmoscope,... · Ophthalmic

Mar 2014 253d

HEINE BETA 200(R) OPHTHALMOSCOPE