The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Mod. 9542 Flow-thru Inject. Temp. Sensor.
| Device ID | K801552 |
| 510k Number | K801552 |
| Device Name: | MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR |
| Classification | Probe, Thermodilution |
| Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-08 |
| Decision Date | 1980-07-28 |