K121712 is an FDA 510(k) clearance for the AIRSTRIP RPM FOR LIFENET CONSULT. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Airstrip Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on November 20, 2012, 162 days after receiving the submission on June 11, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K121712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2012 |
| Decision Date | November 20, 2012 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MSX - System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |