FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SES100
K Number: K940065
·
Decision Dec 6, 1994
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
60
Applicant Total
1
Review Days
334
Basic Information
- Device Name
- SES100
- K Number
- K940065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SOUTHWEST ERGONOMICS
- Date Received
- January 6, 1994
- Decision Date
- December 6, 1994
- Product Code
- ISD
- 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 |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
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