The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Central Venous Pressure Manometer.
| Device ID | K904674 |
| 510k Number | K904674 |
| Device Name: | CENTRAL VENOUS PRESSURE MANOMETER |
| Classification | Manometer, Blood-pressure, Venous |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | KRK |
| CFR Regulation Number | 870.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-12 |
| Decision Date | 1990-12-27 |