FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTO THERM 390, MODEL ME 390
K Number: K042554
·
Decision Oct 8, 2004
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
32
Review Days
18
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Basic Information
- Device Name
- AUTO THERM 390, MODEL ME 390
- K Number
- K042554
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mettler Electronics Corp.
- Date Received
- September 20, 2004
- Decision Date
- October 8, 2004
- 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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|---|---|---|---|
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| K053546 | SONICATOR 740, MODEL ME 740 | May 4, 2006 | Substantially Equivalent |
| K043586 | LASER SYS*STIM 540, MODEL ME 540 | May 6, 2005 | 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 |
| K013192 | SONICATOR PLUS 930, MODEL ME 930 | Oct 17, 2001 | Substantially Equivalent |