K131099 is an FDA 510(k) clearance for the AG MASS. This device is classified as a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II - Special Controls, product code JCX).
Submitted by Hospitech Respiration , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on May 13, 2013, 24 days after receiving the submission on April 19, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K131099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2013 |
| Decision Date | May 13, 2013 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCX - Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |