WIRELESS PHYSIOLOGIC MONITORING SYSTEM
FDA 510(k) clearance K053016 · decided 2005-12-30
Clearance details
- K-number
- K053016
- Device name
- WIRELESS PHYSIOLOGIC MONITORING SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-10-26
- Decision date
- 2005-12-30
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| OptoMonitor 3 (K193620) | Opsens, Inc. | 2020-06-18 |
| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
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| Zurich Pressure Guidewire System Model 100 (K190852) | Zurich Medical, Inc. | 2019-08-14 |
| TruWave Disposable Pressure Transducer (K183413) | Edwards Lifeciences, LLC | 2019-05-01 |
| PressureWire X (K180558) | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
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Recalls involving this device
No recalls on record reference this clearance.