Company ยท CA
Electromed Intl., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2001. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 8 |
| DRX | Electrode, Electrocardiograph | 6 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 |
| LLZ | System, Image Processing, Radiological | 3 |
| GXY | Electrode, Cutaneous | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2001 | K003688 | VIEW READING STATION Electromed Intl., Ltd., CA | LLZ |
| Apr 19, 2000 | K000474 | VIEW NT Electromed Intl., Ltd., CA | LLZ |
| Apr 15, 1999 | K990759 | VIEW COM Electromed Intl., Ltd., CA | LLZ |
| Jan 27, 1998 | K974255 | CD-R STATION AND VRS-2000 Electromed Intl., Ltd., CA | LMD |
| Sep 3, 1997 | K971176 | VIEW ARCHIVING STATION Electromed Intl., Ltd., CA | IZI |
| Mar 31, 1995 | K950694 | COMPACT-X Electromed Intl., Ltd., CA | IZO |
| Feb 29, 1988 | K880050 | EDEC 60R Electromed Intl., Ltd., CA | IZO |
| Feb 1, 1988 | K875341 | EDEC 60 R/F Electromed Intl., Ltd., CA | IZO |
| Jan 29, 1988 | K875342 | EDEC 90C Electromed Intl., Ltd., CA | IZO |
| Mar 31, 1987 | K871145 | EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR Electromed Intl., Ltd., CA | IZO |
| Mar 20, 1987 | K870851 | EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR Electromed Intl., Ltd., CA | IZO |
| Dec 22, 1986 | K864032 | EM TENS WINDOW ELECTRODES Electromed Intl., Ltd. | GXY |
| Dec 8, 1986 | K863584 | EM II STRESS TEST ELECTRODE Electromed Intl., Ltd. | DRX |
| Dec 8, 1986 | K863540 | EM II DISPOSABLE ELECTRODE Electromed Intl., Ltd. | DRX |
| Nov 20, 1986 | K863845 | EM III DISPOSABLE ELECTRODE Electromed Intl., Ltd. | DRX |
| Aug 6, 1986 | K862746 | EM DIAGNOSTIC ECG ELECTRODE Electromed Intl., Ltd. | DRX |
| May 8, 1986 | K860827 | EM STRESS ELECTRODE Electromed Intl., Ltd. | DRX |
| Apr 17, 1986 | K853774 | EM ELECTRODE Electromed Intl., Ltd. | DRX |
| Nov 29, 1985 | K852908 | EDEC 2000 Electromed Intl., Ltd., CA | IZO |
| Mar 1, 1985 | K843443 | EDEC-100 Electromed Intl., Ltd. | IZO |
| Nov 30, 1982 | K823312 | CADIO-RESPIRATORY MONITOR #CR-2 Electromed Intl., Ltd. | DRT |
| Jul 20, 1982 | K821959 | CARDIO-RESPIRATORY MONITOR MODEL CR-1 Electromed Intl., Ltd. | DRT |
| Oct 13, 1981 | K812674 | INFANT CARIDAC MONITOR Electromed Intl., Ltd. | DRT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||