K032403 is an FDA 510(k) clearance for the SMARTMONITOR 2 PROFESSIONAL SERIES (PS). 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 October 27, 2003, 84 days after receiving the submission on August 4, 2003.
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 | K032403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2003 |
| Decision Date | October 27, 2003 |
| Days to Decision | 84 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| 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 |