The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc with the FDA for Esophageal/rectal Temperature Probe And Esophageal Stethoscope With Temperature Sensor.
| Device ID | K072621 |
| 510k Number | K072621 |
| Device Name: | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | CINCINNATI SUB-ZERO PRODUCTS, INC 12011 MOSTELLER ROAD Cincinnati, OH 45241 |
| Contact | Fatma Ali |
| Correspondent | Fatma Ali CINCINNATI SUB-ZERO PRODUCTS, INC 12011 MOSTELLER ROAD Cincinnati, OH 45241 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2007-12-13 |
| Summary: | summary |