MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
FDA 510(k) clearance K021439 · decided 2002-05-29
Clearance details
- K-number
- K021439
- Device name
- MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
- Applicant
- Animas Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-06
- Decision date
- 2002-05-29
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Frazer, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Isulin Pump. Model IR1000 recall (Z-0307-06) | Animas Corporation | 2005-12-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Animas Vibe System (P130007/S036) | Animas Corp. | 2018-07-11 |
| Animas Vibe System (P130007/S035) | Animas Corp. | 2018-04-18 |
| Animas Vibe System (P130007/S034) | Animas Corp. | 2018-03-12 |
| Animas Vibe System (P130007/S033) | Animas Corp. | 2018-03-01 |
| Animas Vibe System (P130007/S027) | Animas Corp. | 2017-10-27 |
| Animas Vibe System (P130007/S031) | Animas Corp. | 2017-10-24 |
| Animas Vibe System (P130007/S029) | Animas Corp. | 2017-08-17 |
| Animas, Vibe System (P130007/S026) | Animas Corp. | 2017-06-09 |