The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Wireless Physiologic Monitoring System.
| Device ID | K053016 |
| 510k Number | K053016 |
| Device Name: | WIRELESS PHYSIOLOGIC MONITORING SYSTEM |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Diane Peterson |
| Correspondent | Diane Peterson EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2005-12-30 |
| Summary: | summary |