The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Flow-directed Pediatric Thermodil- Cath.
| Device ID | K843410 |
| 510k Number | K843410 |
| Device Name: | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH |
| Classification | Probe, Thermodilution |
| Applicant | ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Contact | Robert Tetu |
| Correspondent | Robert Tetu ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-31 |
| Decision Date | 1984-11-20 |