The following data is part of a premarket notification filed by Biosensors Intl. Pte. Ltd. with the FDA for Thermodilution Catheter.
| Device ID | K083384 |
| 510k Number | K083384 |
| Device Name: | THERMODILUTION CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BIOSENSORS INTL. PTE. LTD. 21 KALLANG AVENUE #07-167 Singapore, SG 339412 |
| Contact | Moses Tham |
| Correspondent | Moses Tham BIOSENSORS INTL. PTE. LTD. 21 KALLANG AVENUE #07-167 Singapore, SG 339412 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-11-17 |
| Decision Date | 2010-01-05 |
| Summary: | summary |