PHILIPS BV PULSERA/ENDURA
FDA 510(k) clearance K010435 · decided 2001-03-12
Clearance details
- K-number
- K010435
- Device name
- PHILIPS BV PULSERA/ENDURA
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-13
- Decision date
- 2001-03-12
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Da Best, NL
- Third-party review
- No
- Expedited review
- No
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