FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MR FIBER OPTIC ECG GATING SYSTEM
K Number: K031731
·
Decision Jul 30, 2003
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
1071
Applicant Total
1
Review Days
56
Basic Information
- Device Name
- MR FIBER OPTIC ECG GATING SYSTEM
- K Number
- K031731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SA INSTRUMENTS, INC.
- Date Received
- June 4, 2003
- Decision Date
- July 30, 2003
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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