The following data is part of a premarket notification filed by Regaltech Pty. Ltd. with the FDA for Regaltech Maxiscope.
| Device ID | K921163 |
| 510k Number | K921163 |
| Device Name: | REGALTECH MAXISCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | REGALTECH PTY. LTD. 12 PRINCES ST. COTTESLOE 6011 Western Australia, AU |
| Contact | Maximiliaan Cuypers |
| Correspondent | Maximiliaan Cuypers REGALTECH PTY. LTD. 12 PRINCES ST. COTTESLOE 6011 Western Australia, AU |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-11 |
| Decision Date | 1992-10-27 |