FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROWESS 2000
K Number: K884261
·
Decision Aug 4, 1989
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
2
Review Days
297
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Basic Information
- Device Name
- PROWESS 2000
- K Number
- K884261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Small Systems Group, Inc.
- Date Received
- October 11, 1988
- Decision Date
- August 4, 1989
- Product Code
- KPQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Small Systems Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924240 | PROWESS 2000 | May 17, 1993 | Substantially Equivalent |