The following data is part of a premarket notification filed by Biomedical Sensors, Inc. with the FDA for Cardiomet 4000 Gas Monitoring Systems.
| Device ID | K862069 |
| 510k Number | K862069 |
| Device Name: | CARDIOMET 4000 GAS MONITORING SYSTEMS |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | BIOMEDICAL SENSORS, INC. P.O. BOX 88 GEORGE ST., HIGH WYCOMBE Bucks., England, GB Hp112rz |
| Contact | B. C Crane |
| Correspondent | B. C Crane BIOMEDICAL SENSORS, INC. P.O. BOX 88 GEORGE ST., HIGH WYCOMBE Bucks., England, GB Hp112rz |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-30 |
| Decision Date | 1986-07-18 |