The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Retina Flowmeter.
| Device ID | K943955 |
| 510k Number | K943955 |
| Device Name: | RETINA FLOWMETER |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | HEIDELBERG ENGINEERING OPTISCHE MEB SYSTEME GMBH IM NEUENHEIMER FELD 519 D06900 Heidelberg,germany, DE |
| Contact | Gerhard Zinser |
| Correspondent | Gerhard Zinser HEIDELBERG ENGINEERING OPTISCHE MEB SYSTEME GMBH IM NEUENHEIMER FELD 519 D06900 Heidelberg,germany, DE |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-15 |
| Decision Date | 1994-11-14 |