FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTEL-GE CARE INNOVATIONS QUIETCARE
K Number: K131585
·
Decision Oct 8, 2013
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
30
Applicant Total
3
Review Days
130
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Basic Information
- Device Name
- INTEL-GE CARE INNOVATIONS QUIETCARE
- K Number
- K131585
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intel-Ge Care Innovations, LLC
- Date Received
- May 31, 2013
- Decision Date
- October 8, 2013
- Product Code
- KMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KMI | Monitor, Bed Patient | FDA class 1 | General Hospital |
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