FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARE PAL, MODEL CPW-10X
K Number: K091430
·
Decision Aug 21, 2009
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
3
Review Days
99
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARE PAL, MODEL CPW-10X
- K Number
- K091430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Digio2 International Co., Ltd.
- Date Received
- May 14, 2009
- Decision Date
- August 21, 2009
- Product Code
- DRG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRG), ordered by most recent decision date.
Perin Health System (PHD80060-2)
FDA 510(k)
FDA Class 2
·Cardiovascular
EasyTeleMed (2.0.2)
FDA 510(k)
FDA Class 2
·Cardiovascular
TeleRehab Aermos Cardiopulmonary Rehabilitation
FDA 510(k)
FDA Class 2
·Cardiovascular
iBSM
FDA 510(k)
FDA Class 2
·Cardiovascular
UbiqVue 2A Multi-parameter System (UX2550)
FDA 510(k)
FDA Class 2
·Cardiovascular
BioButton System
FDA 510(k)
FDA Class 2
·Cardiovascular