The following data is part of a premarket notification filed by Circa Scientific, Llc with the FDA for S-cath Esophageal Temperature Probe And Temperature Monitoring System.
| Device ID | K112376 |
| 510k Number | K112376 |
| Device Name: | S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | CIRCA SCIENTIFIC, LLC 14 INVERNESS DRIVE EAST, SUITE H240 Englewood, CO 80112 |
| Contact | Fred Piazza |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2011-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851498007077 | K112376 | 000 |
| 00851498007060 | K112376 | 000 |
| 00851498007053 | K112376 | 000 |
| 00851498007046 | K112376 | 000 |
| 00851498007022 | K112376 | 000 |
| 00851498007015 | K112376 | 000 |
| 30860237000201 | K112376 | 000 |
| 10860237000221 | K112376 | 000 |