FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇩🇪 Germany
SONO 5
K Number: K952536
·
Decision Mar 5, 1996
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
12
Review Days
278
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Basic Information
- Device Name
- SONO 5
- K Number
- K952536
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Zimmer Elektromedizin GmbH
- Date Received
- June 1, 1995
- Decision Date
- March 5, 1996
- 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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Other Clearances by Zimmer Elektromedizin GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K080735 | CRYOMINI | Apr 4, 2008 | Substantially Equivalent |
| K060395 | CRYO, MODEL V6.0 | Feb 24, 2006 | Substantially Equivalent |
| K040727 | CRYO 5 | Apr 23, 2004 | Substantially Equivalent |
| K960969 | GALVA 5-T | May 15, 1996 | Substantially Equivalent |
| K954411 | GALVA-5-M | Feb 28, 1996 | Substantially Equivalent for Some Indications |
| K924473 | DISPOSABLE THERAPY ELECTRODE | May 19, 1993 | Substantially Equivalent |
| K860758 | VACO SUCTION ELECTRODE UNIT | May 2, 1986 | Substantially Equivalent |
| K850006 | TENS | Dec 20, 1985 | Substantially Equivalent for Some Indications |
| K852166 | THERMO SHORTWAVE DIATHERMY | Sep 30, 1985 | Substantially Equivalent for Some Indications |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | May 7, 1985 | Substantially Equivalent |