GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
FDA premarket approval P990026 · decided 2001-03-22
Approval details
- PMA number
- P990026
- Trade name
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Generic name
- INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
- Applicant
- Animas Corp.
- Date received
- 1999-06-01
- Decision date
- 2001-03-22
- Days to decision
- 660 days
- Decision code
- APWD
- Product code
- NCT
- Advisory committee
- Clinical Chemistry
- Expedited review
- Yes
- Location
- West Chester, PA
- Statement
- APPROVAL FOR THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER. THE DEVICE IS INDICATED FOR: THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THE DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE GLUCOWATCH BIOGRAPHER IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD H
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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 |