GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR
FDA premarket approval P990026/S018 · decided 2003-11-20
Approval details
- PMA number
- P990026
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR
- Generic name
- INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
- Applicant
- Animas Corp.
- Date received
- 2003-07-01
- Decision date
- 2003-11-20
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- NCT
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE SIGNAL PROCESSING ROUTINE AND DATA POINT SCREENING PARAMETERS OF THE BIOGRAPHER TO REDUCE THE NUMBER OF SKIPPED READINGS, MODIFICATIONS TO THE DOWN ALERT OF THE BIOGRAPHER TO INCREASE THE SPECIFICITY OF THE ALARM FEATURE AND AN AUTOSENSOR FORMULATION CHANGE TO IMPROVE THE BIOGRAPHER CALIBRATION.
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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 |