The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Access Alert Gauge.
| Device ID | K002372 |
| 510k Number | K002372 |
| Device Name: | ACCESS ALERT GAUGE |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | MEDISYSTEMS CORP. 1201 3RD AVE. Seattle, WA 98101 -3016 |
| Contact | Fredric Swindler |
| Correspondent | Fredric Swindler MEDISYSTEMS CORP. 1201 3RD AVE. Seattle, WA 98101 -3016 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-10-25 |