RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
FDA 510(k) clearance K984545 · decided 1999-02-25
Clearance details
- K-number
- K984545
- Device name
- RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-22
- Decision date
- 1999-02-25
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Da Best, NL
- Third-party review
- No
- Expedited review
- No
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