The following data is part of a premarket notification filed by Reflectance Medical Inc with the FDA for Careguide Oximeter.
| Device ID | K113656 |
| 510k Number | K113656 |
| Device Name: | CAREGUIDE OXIMETER |
| Classification | Oximeter, Tissue Saturation |
| Applicant | REFLECTANCE MEDICAL INC 116 FLAUNDERS ROAD, SUITE 1000 Westborough, MA 01581 |
| Contact | Nandini Murthy |
| Correspondent | Nandini Murthy REFLECTANCE MEDICAL INC 116 FLAUNDERS ROAD, SUITE 1000 Westborough, MA 01581 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-12 |
| Decision Date | 2012-07-26 |
| Summary: | summary |