Heine Optotechnik GmbH & Co. KG
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | May 18, 2015 |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | January 29, 2015 |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | March 7, 2014 |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | December 4, 2013 |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | March 22, 2013 |
| K123316 | HEINE OMEGA 500 | February 26, 2013 |
| K101892 | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.2 | August 27, 2010 |