PICONIBP OEM MODULE
FDA 510(k) clearance K051366 · decided 2005-09-14
Clearance details
- K-number
- K051366
- Device name
- PICONIBP OEM MODULE
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-05-25
- Decision date
- 2005-09-14
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.