The following data is part of a premarket notification filed by Christie Medical Holdings, Inc. with the FDA for Presygen/si-1.
| Device ID | K171245 |
| 510k Number | K171245 |
| Device Name: | Presygen/si-1 |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Christie Medical Holdings, Inc. 3175 Lenox Park Boulevard, Suite 200 Memphis, TN 38115 |
| Contact | Salwa Rezk |
| Correspondent | Diane Horwitz Mandell Horwitz Consultants LLC 2995 Steven Martin Drive Fairfax, VA 20031 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-28 |
| Decision Date | 2018-08-09 |
| Summary: | summary |