The following data is part of a premarket notification filed by Australian Biomedical Corporation Ltd. with the FDA for Voroscope(tm).
| Device ID | K871735 |
| 510k Number | K871735 |
| Device Name: | VOROSCOPE(TM) |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | AUSTRALIAN BIOMEDICAL CORPORATION LTD. 39 DEHAVILLAND ROAD MORDIALLOC, VIC. 3195 Australia, AU |
| Contact | David Whitehead |
| Correspondent | David Whitehead AUSTRALIAN BIOMEDICAL CORPORATION LTD. 39 DEHAVILLAND ROAD MORDIALLOC, VIC. 3195 Australia, AU |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-05 |
| Decision Date | 1987-06-03 |