The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Extracorporeal Temperature Sensor.
| Device ID | K935603 |
| 510k Number | K935603 |
| Device Name: | EXTRACORPOREAL TEMPERATURE SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 2552 MCGAW AVE. Irvine, CA 92714 |
| Contact | Kerry Tomic |
| Correspondent | Kerry Tomic SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 2552 MCGAW AVE. Irvine, CA 92714 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-02-15 |