The following data is part of a premarket notification filed by Epocal Inc. with the FDA for Epoc Blood Analysis System.
| Device ID | K200107 |
| 510k Number | K200107 |
| Device Name: | Epoc Blood Analysis System |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | Epocal Inc. 2060 Walkley Road Ottawa, CA K1g 3p5 |
| Contact | Amanda Barriage |
| Correspondent | Amy Goldberg Epocal Inc. 2060 Walkley Road Ottawa, CA K1g 3p5 |
| Product Code | CHL |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGL |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JPI |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-17 |
| Decision Date | 2020-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414606095 | K200107 | 000 |