XUB EXTERNAL ULTRASOUND— 510(k) K010702
Substantially EquivalentKmi Kolster Methods, Inc.
FDA 510(k) clearance K010702 for XUB EXTERNAL ULTRASOUND, Substantially Equivalent on 2001-08-09. Applicant: Kmi Kolster Methods, Inc.. Device class: 2.
Clearance details
- Applicant
- Kmi Kolster Methods, Inc.
- Product code
- Code IMI
- Device class
- Class 2
- Regulation
- 21 CFR 890.5300
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
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