MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL— 510(k) K003366
Substantially EquivalentIgc-Medical Advances, Inc.
FDA 510(k) clearance K003366 for MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL, Substantially Equivalent on 2000-12-22. Applicant: Igc-Medical Advances, Inc.. Device class: 2.
Clearance details
- Applicant
- Igc-Medical Advances, 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
- Traditional
- Location
- Milwaukee, WI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.