FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
SPIFFY
K Number: K945650
·
Decision Dec 19, 1994
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
25
Applicant Total
1
Review Days
32
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Basic Information
- Device Name
- SPIFFY
- K Number
- K945650
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thames Valley Children'S Centre
- Date Received
- November 17, 1994
- Decision Date
- December 19, 1994
- Product Code
- INN
- 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 |
|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | FDA class 1 | Physical Medicine |
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