FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONICATOR PLUS 930, MODEL ME 930
K Number: K013192
·
Decision Oct 17, 2001
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
32
Review Days
22
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Basic Information
- Device Name
- SONICATOR PLUS 930, MODEL ME 930
- K Number
- K013192
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mettler Electronics Corp.
- Date Received
- September 25, 2001
- Decision Date
- October 17, 2001
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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| K043586 | LASER SYS*STIM 540, MODEL ME 540 | May 6, 2005 | Substantially Equivalent |
| K042554 | AUTO THERM 390, MODEL ME 390 | Oct 8, 2004 | Substantially Equivalent |
| K031017 | SYS*STIM 208 AND 208A | May 30, 2003 | Substantially Equivalent |
| K023083 | SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 | Feb 28, 2003 | Substantially Equivalent - Subject to Tracking Reg. |
| K022458 | AUTO*THERM 395, MODEL ME 395 | Sep 26, 2002 | Substantially Equivalent |