The following data is part of a premarket notification filed by Sunscope Intl., Inc. with the FDA for Biosensors Central Venous Catheter Kits.
| Device ID | K002786 |
| 510k Number | K002786 |
| Device Name: | BIOSENSORS CENTRAL VENOUS CATHETER KITS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SUNSCOPE INTL., INC. 20250 ACACIA ST., SUITE 115 Newport Beach, CA 92660 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider SUNSCOPE INTL., INC. 20250 ACACIA ST., SUITE 115 Newport Beach, CA 92660 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-07 |
| Decision Date | 2000-11-17 |