The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Smartmonitor 2ps.
| Device ID | K061256 |
| 510k Number | K061256 |
| Device Name: | SMARTMONITOR 2PS |
| 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 | 2006-05-04 |
| Decision Date | 2006-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0361038141 | K061256 | 000 |
| B0361038140 | K061256 | 000 |
| B0361030271 | K061256 | 000 |
| B0361028971 | K061256 | 000 |
| B0361028970 | K061256 | 000 |
| B0361014557 | K061256 | 000 |