FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions
PMA: P810044
·
Supplement: S002
·
Decision Apr 27, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions
- Trade Name
- SLEEP SENTRY(TM)
- PMA Number
- P810044
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LMY
- Generic Name
- Monitor, skin resistance/skin temperature, for insulin reactions
- Medical Specialty
- Unknown
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 27, 1983
- Date Received
- March 16, 1983
- Expedited Review
- N
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMY | Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions | FDA class 3 | Unknown |