Electromed Intl., Ltd.
St-Eustache, Quebec, CA
Electromed Intl., Ltd. appears in FDA device records in St-Eustache, Quebec, CA. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Electromed Intl., Ltd. between 1981 and 2001. The busiest year on record is 1986, with 7. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 2 |
| 1985 | 2 |
| 1986 | 7 |
| 1987 | 2 |
| 1988 | 3 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003688 | VIEW READING STATION | LLZ | Substantially Equivalent | |
| K000474 | VIEW NT | LLZ | Substantially Equivalent | |
| K990759 | VIEW COM | LLZ | Substantially Equivalent | |
| K974255 | CD-R STATION AND VRS-2000 | LMD | Substantially Equivalent | |
| K971176 | VIEW ARCHIVING STATION | IZI | Substantially Equivalent | |
| K950694 | COMPACT-X | IZO | Substantially Equivalent | |
| K880050 | EDEC 60R | IZO | Substantially Equivalent | |
| K875341 | EDEC 60 R/F | IZO | Substantially Equivalent | |
| K875342 | EDEC 90C | IZO | Substantially Equivalent | |
| K871145 | EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR | IZO | Substantially Equivalent | |
| K870851 | EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR | IZO | Substantially Equivalent | |
| K864032 | EM TENS WINDOW ELECTRODES | GXY | Substantially Equivalent | |
| K863584 | EM II STRESS TEST ELECTRODE | DRX | Substantially Equivalent | |
| K863540 | EM II DISPOSABLE ELECTRODE | DRX | Substantially Equivalent | |
| K863845 | EM III DISPOSABLE ELECTRODE | DRX | Substantially Equivalent | |
| K862746 | EM DIAGNOSTIC ECG ELECTRODE | DRX | Substantially Equivalent | |
| K860827 | EM STRESS ELECTRODE | DRX | Substantially Equivalent | |
| K853774 | EM ELECTRODE | DRX | Substantially Equivalent | |
| K852908 | EDEC 2000 | IZO | Substantially Equivalent | |
| K843443 | EDEC-100 | IZO | Substantially Equivalent | |
| K823312 | CADIO-RESPIRATORY MONITOR #CR-2 | DRT | Substantially Equivalent | |
| K821959 | CARDIO-RESPIRATORY MONITOR MODEL CR-1 | DRT | Substantially Equivalent | |
| K812674 | INFANT CARIDAC MONITOR | DRT | 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