FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUJITENS III
K Number: K893874
·
Decision Dec 22, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
3
Review Days
210
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Basic Information
- Device Name
- FUJITENS III
- K Number
- K893874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Altoona Medical Supply
- Date Received
- May 26, 1989
- Decision Date
- December 22, 1989
- Product Code
- GZQ
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GZQ | Instrument, Dowel Cutting | FDA class 2 | Neurology |