The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Edan I15 Blood Gas And Chemistry Analysis System, Edan I15 Calibrant Fluid Pack, Edan I15 Blood Gas And Electrolyte Control, Edan I15 Hematocrit Control.
| Device ID | K151978 |
| 510k Number | K151978 |
| Device Name: | EDAN I15 Blood Gas And Chemistry Analysis System, EDAN I15 Calibrant Fluid Pack, EDAN I15 Blood Gas And Electrolyte Control, EDAN I15 Hematocrit Control |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, #1019 NANHAI ROAD Shenzhen, CN 518067 |
| Contact | Tracy Yue |
| Correspondent | Randy Byrd RANDY BYRD, LLC 1 BLUEBERRY HILL WAY Pepperell, MA 01463 -4200 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKF |
| Subsequent Product Code | GLK |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJS |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-17 |
| Decision Date | 2016-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413803145 | K151978 | 000 |
| 06944413801981 | K151978 | 000 |
| 06944413801998 | K151978 | 000 |
| 06944413802001 | K151978 | 000 |
| 06944413802018 | K151978 | 000 |
| 06944413802025 | K151978 | 000 |
| 06944413802865 | K151978 | 000 |
| 06944413802919 | K151978 | 000 |
| 06944413802940 | K151978 | 000 |
| 06944413803107 | K151978 | 000 |
| 06944413801875 | K151978 | 000 |