The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Single Channel Brain Stem Response Audiometer Bsr2.
| Device ID | K854533 |
| 510k Number | K854533 |
| Device Name: | SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Contact | Gleason |
| Correspondent | Gleason MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1986-09-30 |