The following data is part of a premarket notification filed by Biosensors International-usa with the FDA for Cardiac Output Kit, Model Co-1 & Inline Sensor Cable, Model Ils-1.
| Device ID | K022004 |
| 510k Number | K022004 |
| Device Name: | CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BIOSENSORS INTERNATIONAL-USA 20250 ACACIA ST., SUITE 115 Newport Beach, CA 92660 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider BIOSENSORS INTERNATIONAL-USA 20250 ACACIA ST., SUITE 115 Newport Beach, CA 92660 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-19 |
| Decision Date | 2003-03-12 |
| Summary: | summary |