CVI-Q(TM) OPTION FOR P700
FDA 510(k) clearance K924184 · decided 1993-12-10
Clearance details
- K-number
- K924184
- Device name
- CVI-Q(TM) OPTION FOR P700
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-20
- Decision date
- 1993-12-10
- Days to decision
- 477 days
- Clearance type
- Traditional
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.