FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
BOOST, MICE, GAMESYS.
K Number: K924416
·
Decision Jun 15, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
3
Review Days
288
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Basic Information
- Device Name
- BOOST, MICE, GAMESYS.
- K Number
- K924416
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Penny and Giles Biometrics , Ltd.
- Date Received
- August 31, 1992
- Decision Date
- June 15, 1993
- Product Code
- KQX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| KQX | Goniometer, Ac-Powered | FDA class 1 | Orthopedic |
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