The following data is part of a premarket notification filed by Medusa Medical Technologies Inc. with the FDA for Siren Epcr Suite.
| Device ID | K131272 |
| 510k Number | K131272 |
| Device Name: | SIREN EPCR SUITE |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | MEDUSA MEDICAL TECHNOLOGIES INC. 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
| Contact | Diane Sudduth |
| Correspondent | Diane Sudduth MEDUSA MEDICAL TECHNOLOGIES INC. 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-03 |
| Decision Date | 2014-01-03 |
| Summary: | summary |