FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT CARDIAC ARRAY
K Number: K083539
·
Decision Apr 3, 2009
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
3
Review Days
126
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Basic Information
- Device Name
- INFANT CARDIAC ARRAY
- K Number
- K083539
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Imaging Research, Inc.
- Date Received
- November 28, 2008
- Decision Date
- April 3, 2009
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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