PMA P810044S004

Device: SLEEP SENTRY
Applicant: Diabetes Sentry Products, LLC
PMA number: P810044
Supplement: S004
Product code: LMY
Decision date: 2003-06-12
Classification: General Hospital
Generic name: Monitor, skin resistance/skin temperature, for insulin reactions
Approval order statement: APPROVAL FOR CHANGES TO THE PHYSICAL DESIGN AND LAYOUT OF THE DEVICE, DEVICE LABELING, AND MANUFACTURING FACILITIES AND PROCESSES. THE MANUFACTURING SITES ARE LOCATED AT DIABETES SENTRY PRODUCTS, INC. (DSP), BELLINGHAM WASHINGTON AND DATREND SYSTEMS, INC., RICHMOND, BC CANADA.

Current openFDA PMA Record#

Device: SLEEP SENTRY
Applicant: Diabetes Sentry Products, LLC
PMA number: P810044
Supplement: S004
Product code: LMY
Generic name: Monitor, skin resistance/skin temperature, for insulin reactions
Decision date: 2003-06-12
Decision code: APPR
Date received: 2002-04-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE PHYSICAL DESIGN AND LAYOUT OF THE DEVICE, DEVICE LABELING, AND MANUFACTURING FACILITIES AND PROCESSES. THE MANUFACTURING SITES ARE LOCATED AT DIABETES SENTRY PRODUCTS, INC. (DSP), BELLINGHAM WASHINGTON AND DATREND SYSTEMS, INC., RICHMOND, BC CANADA.