The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Baltherm Tlc Thermal Dilution.
| Device ID | K831945 |
| 510k Number | K831945 |
| Device Name: | ELECATH BALTHERM TLC THERMAL DILUTION |
| Classification | Catheter, Flow Directed |
| Applicant | ELECTRO-CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-16 |
| Decision Date | 1983-08-12 |