9600 FLUOROSCOPIC IMAGING SYSTEM
FDA 510(k) clearance K926056 · decided 1993-01-21
Clearance details
- K-number
- K926056
- Device name
- 9600 FLUOROSCOPIC IMAGING SYSTEM
- Applicant
- Oec-Diasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-01
- Decision date
- 1993-01-21
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- OXO
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.