E-SCAN MRI SYSTEM— 510(k) K012728
Substantially EquivalentBiosound Esaote, Inc.
FDA 510(k) clearance K012728 for E-SCAN MRI SYSTEM, Substantially Equivalent on 2001-08-29. Applicant: Biosound Esaote, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosound Esaote, Inc.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
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More clearances from Biosound Esaote, Inc.
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