GLUCOWATCH 2 BIOGRAPHER
FDA premarket approval P990026/S011 · decided 2002-03-21
Approval details
- PMA number
- P990026
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GLUCOWATCH 2 BIOGRAPHER
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Applicant
- Animas Corp.
- Date received
- 2001-12-11
- Decision date
- 2002-03-21
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- CGA
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ELECTRICAL HARDWARE AND SOFTWARE OF THE ORIGINAL GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLUCOWATCH2 BIOGRAPHER AND IS INDICATED FOR: THE GLUCOWATCH2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INTENDED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTHCARE FACILITIES. THE DEVICE IS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |
| EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587) | Animas Corp. | 2008-05-15 |
| EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE (K063674) | Animas Corp. | 2007-03-30 |
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |
| MODEL IR 1200 INSULIN PUMP (K032257) | Animas Corp. | 2003-10-16 |
| EZMANAGER PLUS (K022394) | Animas Corp. | 2003-06-05 |
| ANIMUS EZSERTER INFUSION SET INSERTER (K021700) | Animas Corp. | 2002-06-04 |
| MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO (K021439) | Animas Corp. | 2002-05-29 |