FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELICOR, MODELS A100 & D100
K Number: K020227
·
Decision Jul 30, 2002
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
2
Review Days
189
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Basic Information
- Device Name
- SELICOR, MODELS A100 & D100
- K Number
- K020227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Selicor, Inc.
- Date Received
- January 22, 2002
- Decision Date
- July 30, 2002
- Product Code
- IMJ
- 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 |
|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Selicor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030382 | SELITHERM, MODEL C100 | Apr 1, 2003 | Substantially Equivalent |