The following data is part of a premarket notification filed by Epocal, Inc. with the FDA for Epoc Blood Analysis System.
| Device ID | K061597 |
| 510k Number | K061597 |
| Device Name: | EPOC BLOOD ANALYSIS SYSTEM |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | EPOCAL, INC. 2935 CONROY ROAD Ottawa, CA K1g 6c6 |
| Contact | Roy Layer |
| Correspondent | Roy Layer EPOCAL, INC. 2935 CONROY ROAD Ottawa, CA K1g 6c6 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414606460 | K061597 | 000 |