ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
FDA 510(k) clearance K072621 · decided 2007-12-13
Clearance details
- K-number
- K072621
- Device name
- ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
- Applicant
- Cincinnati Sub-Zero Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-17
- Decision date
- 2007-12-13
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- BZT
- Device class
- 2
- Regulation number
- 868.1920
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Sharonville, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, P recall (Z-0372-2012) | Cincinnati Sub-Zero Products Inc | 2012-01-11 |