K130320 is an FDA 510(k) clearance for the BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on February 4, 2014, 361 days after receiving the submission on February 8, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K130320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2013 |
| Decision Date | February 04, 2014 |
| Days to Decision | 361 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |