SYMPHONY GLUCOSE MANAGEMENT SYSTEM
FDA 510(k) clearance K080639 · decided 2008-06-24
Clearance details
- K-number
- K080639
- Device name
- SYMPHONY GLUCOSE MANAGEMENT SYSTEM
- Applicant
- Animas Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-06
- Decision date
- 2008-06-24
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deli recall (Z-1376-2012) | Animas Corporation | 2012-04-06 |
| One Touch Ping Glucose Management Systems Intended use: deliver insulin therapy recall (Z-2394-2010) | Animas Corporation | 2010-09-10 |
| One Touch Ping Insulin Pump using ezManager Max diabetes management software recall (Z-1560-2010) | Animas Corporation | 2010-05-08 |
| Meter Remote for OneTouch Ping Glucose Management System recall (Z-0955-2009) | Animas Corporation | 2009-03-03 |
| Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to h recall (Z-0290-2009) | Animas Corporation | 2008-11-25 |
| Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help m recall (Z-0291-2009) | Animas Corporation | 2008-11-25 |
| One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping (T recall (Z-0283-2009) | Animas Corporation | 2008-11-07 |
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 |