The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Smartmonitor 2 Professional Series (ps).
| Device ID | K032403 |
| 510k Number | K032403 |
| Device Name: | SMARTMONITOR 2 PROFESSIONAL SERIES (PS) |
| Classification | Monitor, Apnea, Home Use |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | NPF |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-10-27 |
| Summary: | summary |