Airway Thermistor
FDA 510(k) K914219 · Synectics-Dantec
510(k) numberK914219
Submission
- Device name
- Airway Thermistor
- Applicant
- Synectics-Dantec
Irving, TX, US - Received
- September 19, 1991
- Decision date
- February 26, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K924383 | Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional | 06/18/1993SE |
| K913817 | Monocrystant Ph-Reference Catheter, ModificationFFT · Traditional | 06/11/1992SE |
| K914624 | PH Meter, ModificationFFT · Traditional | 04/28/1992SE |
| K913387 | Digitrapper Mark IIIFFT · Traditional | 12/27/1991SE |
| K904625 | Synectics Liberty System, PC Polygraf and PolygramBZG · Traditional | 08/20/1991SE |
| K905520 | Microtrapper/Microdigitrapper, ModificationBZQ · Traditional | 04/26/1991SE |
Questions and answers
When was Airway Thermistor cleared by the FDA?
Airway Thermistor (K914219) received a 510(k) decision of Substantially Equivalent on February 26, 1992, 160 days after the submission was received.
What is the product code of K914219?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.