PMA P990026S018

Device: GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR
Applicant: Animas Corp.
PMA number: P990026
Supplement: S018
Product code: NCT
Decision date: 2003-11-20
Classification: Clinical Chemistry
Generic name: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
Approval order 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.

Current openFDA PMA Record#

Device: GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR
Applicant: Animas Corp.
PMA number: P990026
Supplement: S018
Product code: NCT
Generic name: INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
Decision date: 2003-11-20
Decision code: APPR
Date received: 2003-07-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.