PHILIPS INTEGRIS H5000
FDA 510(k) clearance K971365 · decided 1997-05-14
Clearance details
- K-number
- K971365
- Device name
- PHILIPS INTEGRIS H5000
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-14
- Decision date
- 1997-05-14
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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