The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Vps 2250, Csu2250 & Vfu 2250.
| Device ID | K844659 |
| 510k Number | K844659 |
| Device Name: | VPS 2250, CSU2250 & VFU 2250 |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Contact | David E Abraham |
| Correspondent | David E Abraham MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-26 |
| Decision Date | 1985-02-25 |