Madsen Electronics (Canada), Ltd.
Oakville, Ontario, CA
Madsen Electronics (Canada) , Ltd. appears in FDA device records in Oakville, Ontario, CA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Madsen Electronics (Canada), Ltd. between 1985 and 1994. The busiest year on record is 1985, with 4. The most recent is 1994, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 4 |
| 1986 | 4 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K942749 | HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT | ESD | Substantially Equivalent | |
| K931325 | OTOACOUSTIC EMISSIONS UNIT CELESTA 503 | EWO | Substantially Equivalent | |
| K931324 | ORBITER 922 CLINICAL AUDIOMETER | EWO | Substantially Equivalent | |
| K910247 | ZODIAC 901 MIDDLE-EAR ANALYZER | ETY | Substantially Equivalent | |
| K884372 | MADSEN IGO1500 INSERTION GAIN OPTIMIZER | ETW | Substantially Equivalent | |
| K884371 | MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM | ETW | Substantially Equivalent | |
| K883478 | DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 | EWO | Substantially Equivalent | |
| K874354 | AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020 | ETY | Substantially Equivalent | |
| K870229 | HEARING AID TEST SYSTEM MODEL HAT 1000 | ETW | Substantially Equivalent | |
| K861905 | PLOTTER MODEL (MP100) | Substantially Equivalent | ||
| K854533 | SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 | Substantially Equivalent | ||
| K854535 | INSERTION GAIN OPTIMIZER IGO-1000 | ETW | Substantially Equivalent | |
| K854534 | DIGITAL SCREENING AUDIOMETER DSA6214 | EWO | Substantially Equivalent | |
| K845050 | UP800 A UNIVERSAL PRINTER | EWO | Substantially Equivalent | |
| K844592 | MTA 86 | Substantially Equivalent | ||
| K845049 | Z0174, IMPEDANCE AUDIOMETER | ETY | Substantially Equivalent | |
| K844659 | VPS 2250, CSU2250 & VFU 2250 | GWE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain