FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROMATRON 3000
K Number: K901566
·
Decision Oct 29, 1990
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
60
Applicant Total
1
Review Days
209
Basic Information
- Device Name
- PROMATRON 3000
- K Number
- K901566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Promatek Medical Systems, Inc.
- Date Received
- April 3, 1990
- Decision Date
- October 29, 1990
- Product Code
- IKK
- 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | FDA class 2 | Physical Medicine |
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