The following data is part of a premarket notification filed by Sendx Medical Inc. with the FDA for Abl80 Flex Co-ox With Aqure Connectivity.
| Device ID | K151856 |
| 510k Number | K151856 |
| Device Name: | ABL80 FLEX CO-OX With AQURE Connectivity |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | SENDX MEDICAL INC. 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Contact | Vibeke Agerlin |
| Correspondent | Lasse Post Moller RADIOMETER MEDICAL APS. AAKANDEVEJ 21 Broenshoej, DK 2700 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-08 |
| Decision Date | 2015-08-06 |
| Summary: | summary |