FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XUB EXTERNAL ULTRASOUND
K Number: K010702
·
Decision Aug 9, 2001
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
6
Review Days
154
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Basic Information
- Device Name
- XUB EXTERNAL ULTRASOUND
- K Number
- K010702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kmi Kolster Methods, Inc.
- Date Received
- March 8, 2001
- Decision Date
- August 9, 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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Other Clearances by Kmi Kolster Methods, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060414 | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE | Oct 23, 2006 | Substantially Equivalent |
| K043591 | FEATHERLIFT EXTENDED APTOS THREAD | Mar 4, 2005 | Substantially Equivalent |
| K012236 | STARS2000 POWER CANNULA | Nov 19, 2001 | Substantially Equivalent |
| K002859 | SSW-STERILE SOLUTION WARMER | Nov 16, 2000 | Substantially Equivalent |
| K991203 | IRRIGATION OR INFUSION PUMP K PUMP | Oct 15, 1999 | Substantially Equivalent |