FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOVA PILLOW
K Number: K895477
·
Decision Jan 10, 1990
Classifications
1
FEI Numbers
297
Registration Numbers
297
Same Product Code
26
Applicant Total
3
Review Days
121
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Basic Information
- Device Name
- NOVA PILLOW
- K Number
- K895477
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Nova Health Systems, Inc.
- Date Received
- September 11, 1989
- Decision Date
- January 10, 1990
- Product Code
- IQK
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQK | Orthosis, Cervical | FDA class 1 | Physical Medicine |
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