FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
K Number: K072621
·
Decision Dec 13, 2007
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
45
Applicant Total
12
Review Days
87
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Basic Information
- Device Name
- ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
- K Number
- K072621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1920
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cincinnati Sub-Zero Products, Inc.
- Date Received
- September 17, 2007
- Decision Date
- December 13, 2007
- Product Code
- BZT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZT | Stethoscope, Esophageal, With Electrical Conductors | FDA class 2 | Anesthesiology |
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ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
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ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
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Other Clearances by Cincinnati Sub-Zero Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS | Jan 17, 2013 | Substantially Equivalent |
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | Dec 18, 2012 | Substantially Equivalent |
| K121669 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) | Jul 3, 2012 | Substantially Equivalent |
| K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS | Feb 17, 2012 | Substantially Equivalent |
| K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM | Feb 4, 2011 | Substantially Equivalent |
| K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS | Oct 1, 2010 | Substantially Equivalent |
| K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS | Sep 20, 2010 | Substantially Equivalent |
| K070339 | DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES | Sep 26, 2007 | Substantially Equivalent |
| K942790 | WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) | Jan 24, 1995 | Substantially Equivalent |
| K942599 | WARM AIR WARMING UNIT | Jan 24, 1995 | Substantially Equivalent |