FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONICATOR PLUS
K Number: K921436
·
Decision Apr 27, 1993
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
32
Review Days
398
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Basic Information
- Device Name
- SONICATOR PLUS
- K Number
- K921436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mettler Electronics Corp.
- Date Received
- March 25, 1992
- Decision Date
- April 27, 1993
- Product Code
- IMG
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Mettler Electronics Corp.
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|---|---|---|---|
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| K091540 | MTD 4000 | Oct 8, 2009 | Substantially Equivalent |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | Aug 1, 2007 | Substantially Equivalent |
| K053546 | SONICATOR 740, MODEL ME 740 | May 4, 2006 | Substantially Equivalent |
| 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 |