The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Zodiac 901 Middle-ear Analyzer.
| Device ID | K910247 |
| 510k Number | K910247 |
| Device Name: | ZODIAC 901 MIDDLE-EAR ANALYZER |
| Classification | Tester, Auditory Impedance |
| Applicant | MADSEN ELECTRONICS (CANADA) LTD. 908 NIGRARA FALLS BLVD. North Tonawanda, NY 14220 -2060 |
| Contact | George Pay |
| Correspondent | George Pay MADSEN ELECTRONICS (CANADA) LTD. 908 NIGRARA FALLS BLVD. North Tonawanda, NY 14220 -2060 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315005053 | K910247 | 000 |
| 05713315002205 | K910247 | 000 |
| 05713315002199 | K910247 | 000 |
| 05713315002182 | K910247 | 000 |
| 05713315002304 | K910247 | 000 |
| 05713315002311 | K910247 | 000 |
| 05713315002298 | K910247 | 000 |
| 05713315002281 | K910247 | 000 |
| 05713315002274 | K910247 | 000 |
| 05713315002267 | K910247 | 000 |
| 05713315002212 | K910247 | 000 |
| 05713315002229 | K910247 | 000 |
| 05713315003936 | K910247 | 000 |
| 05713315002373 | K910247 | 000 |
| 05713315002366 | K910247 | 000 |
| 05713315002243 | K910247 | 000 |
| 05713315003707 | K910247 | 000 |
| 05713315003691 | K910247 | 000 |
| 05713315003738 | K910247 | 000 |
| 05713315003721 | K910247 | 000 |
| 05713315003714 | K910247 | 000 |
| 05713315002441 | K910247 | 000 |