The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Retina Tomograph And Flowmeter.
Device ID | K943956 |
510k Number | K943956 |
Device Name: | RETINA TOMOGRAPH AND 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 |