The following data is part of a premarket notification filed by Centauri Medical, Inc. with the FDA for Dynasense System.
| Device ID | K130752 |
| 510k Number | K130752 |
| Device Name: | DYNASENSE SYSTEM |
| Classification | Monitor, Bed Patient |
| Applicant | CENTAURI MEDICAL, INC. 755 N MATHILDA AVE STE 100 Sunnyvale, CA 94085 |
| Contact | Lori Adels |
| Correspondent | Lori Adels CENTAURI MEDICAL, INC. 755 N MATHILDA AVE STE 100 Sunnyvale, CA 94085 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-19 |
| Decision Date | 2013-08-15 |
| Summary: | summary |