FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUDDLE HEART -AUDITORY/VIBRATION DEVICE
K Number: K845002
·
Decision Apr 23, 1986
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
26
Applicant Total
3
Review Days
483
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Basic Information
- Device Name
- CUDDLE HEART -AUDITORY/VIBRATION DEVICE
- K Number
- K845002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5140
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- International Purchasing Services
- Date Received
- December 26, 1984
- Decision Date
- April 23, 1986
- Product Code
- FMS
- 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 |
|---|---|---|---|
| FMS | Bed, Pediatric Open Hospital | FDA class 2 | General Hospital |
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