PMA P810044
- Device
- Sleep Sentry(tm)
- Applicant
- DIABETES SENTRY PRODUCTS, LLC
- PMA number
- P810044
- Supplement
- S003
- Decision date
- 1984-05-03
Current openFDA PMA Record
- Device
- DIABETES SENTRY
- Applicant
- Diabetes Sentry Products, LLC
- PMA number
- P810044
- Supplement
- S005
- Product code
- LMY
- Generic name
- Monitor, skin resistance/skin temperature, for insulin reactions
- Decision date
- 2005-04-08
- Decision code
- APPR
- Date received
- 2005-02-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE CHANGE OF THE DEVICE WEB ADDRESS, AND A CHANGE TO THE NAME OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIABETES SENTRY.