FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECTRO-SAGE MODEL 203
K Number: K842379
·
Decision Aug 10, 1984
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
3
Review Days
53
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Basic Information
- Device Name
- ELECTRO-SAGE MODEL 203
- K Number
- K842379
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Weingart, Inc.
- Date Received
- June 18, 1984
- Decision Date
- August 10, 1984
- Product Code
- IRO
- 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | FDA class 1 | Physical Medicine |
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