Thermistor Cannula Style,Single Element,Adam Shell Thermistor Airflow Sensor
FDA 510(k) K960851 · Pro-Tech Services, Inc.
510(k) numberK960851
Submission
- Device name
- Thermistor Cannula Style,Single Element,Adam Shell Thermistor Airflow Sensor
- Applicant
- Pro-Tech Services, Inc.
Woodinville, WA, US - Received
- March 1, 1996
- Decision date
- September 17, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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More from Linshom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K053063 | Pro-Flow Multipurpose CannulaCCK · Traditional | 12/13/2005SE |
| K033402 | Portable Sleep Data Recorder (PSDR)MNR · Traditional | 06/30/2004SE |
| K013905 | Modification EZ-1 System Repiratory SensorsMNR · Special | 04/22/2002SE |
| K982293 | Pressure Transducer Airflow SensorMNR · Special | 07/13/1998SE |
| K972515 | Sensor AmplifierGWL · Traditional | 10/02/1997SE |
| K944175 | Adam Shell Thermocouple AssemblyBZG · Traditional | 10/14/1994SE |
Questions and answers
When was Thermistor Cannula Style,Single Element,Adam Shell Thermistor Airflow Sensor cleared by the FDA?
Thermistor Cannula Style,Single Element,Adam Shell Thermistor Airflow Sensor (K960851) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on September 17, 1996, 200 days after the submission was received.
What is the product code of K960851?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.