FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL PMT850
K Number: K070931
·
Decision May 24, 2007
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
14
Applicant Total
2
Review Days
51
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Basic Information
- Device Name
- MODEL PMT850
- K Number
- K070931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promedtek, Inc.
- Date Received
- April 3, 2007
- Decision Date
- May 24, 2007
- Product Code
- ILX
- 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 |
|---|---|---|---|
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Promedtek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Nov 17, 2016 | Substantially Equivalent |