RAHD 3100
FDA 510(k) clearance K903313 · decided 1991-10-07
Clearance details
- K-number
- K903313
- Device name
- RAHD 3100
- Applicant
- Esm , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-24
- Decision date
- 1991-10-07
- Days to decision
- 440 days
- Clearance type
- Traditional
- Product code
- KPQ
- Device class
- 2
- Regulation number
- 892.5840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ft. Lewis, MO, US
- Third-party review
- No
- Expedited review
- No
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| ADVANTAGE SIM MD (K052345) | GE Healthcare | 2005-09-14 |
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Recalls involving this device
No recalls on record reference this clearance.