The following data is part of a premarket notification filed by Carefusion 303, Inc. with the FDA for Wireless Monitoring System.
| Device ID | K110809 |
| 510k Number | K110809 |
| Device Name: | WIRELESS MONITORING SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | CAREFUSION 303, INC. 115 MITON PARK BUILDING 3 Abingdon,oxon, GB Ox 14 4rz |
| Contact | Simon Pearmain |
| Correspondent | Simon Pearmain CAREFUSION 303, INC. 115 MITON PARK BUILDING 3 Abingdon,oxon, GB Ox 14 4rz |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2011-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060403780065 | K110809 | 000 |