American Electromedics Corp.
Mchenry, IL, US
American Electromedics Corp. appears in FDA device records in Mchenry, IL. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for American Electromedics Corp. between 1982 and 1998. The busiest year on record is 1998, with 4. The most recent is 1998, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1993 | 3 |
| 1995 | 2 |
| 1997 | 2 |
| 1998 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983051 | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | ETY | Substantially Equivalent | |
| K983049 | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER | ETY | Substantially Equivalent | |
| K983048 | AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | EWO | Substantially Equivalent | |
| K983046 | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER | ETY | Substantially Equivalent | |
| K972221 | K 15 AUDIOMETER | EWO | Substantially Equivalent | |
| K970279 | RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) | EWO | Substantially Equivalent | |
| K955289 | RACE CAR TYMPANOMETER | ETY | Substantially Equivalent | |
| K951527 | THE PILOT AUDIOMETER | EWO | Substantially Equivalent | |
| K930164 | THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S | ETY | Substantially Equivalent | |
| K924934 | AUTOMATIC IMPEDANCE METER AE-205 | ETY | Substantially Equivalent | |
| K924933 | AE-206 TYMPNOMWRWE(R) AUDIOMETER | ETY | Substantially Equivalent | |
| K905213 | MIDDLE EAR ANALYZER, MODEL AE-803 | ETY | Substantially Equivalent | |
| K905212 | IMMITTANCE METER, MODEL AE-105D/S | ETY | Substantially Equivalent | |
| K894260 | AE-105D DIAGNOSTIC TYMPANOMETER | ETY | Substantially Equivalent | |
| K883728 | AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER | ETY | Substantially Equivalent | |
| K881402 | 629V SPIROMETER, PULMONARY FUNCTION ANALYZER | BZG | Substantially Equivalent | |
| K881760 | AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER | EWO | Substantially Equivalent | |
| K833045 | CLINICAL TYMPANOMETER | ETY | Substantially Equivalent | |
| K837029 | ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE | Substantially Equivalent | ||
| K822745 | THE SCREENING TYMPANOMETER | EWO | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain