K061256 is an FDA 510(k) clearance for the SMARTMONITOR 2PS. This device is classified as a Monitor, Apnea, Home Use (Class II - Special Controls, product code NPF).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on August 2, 2006, 90 days after receiving the submission on May 4, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2377. Same As The Identification For Product Code Fls, Just Add Home Use.
| 510(k) Number | K061256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2006 |
| Decision Date | August 02, 2006 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | NPF — Monitor, Apnea, Home Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2377 |
| Definition | Same As The Identification For Product Code Fls, Just Add Home Use |