Microtrapper/Microdigitrapper, Modification
FDA 510(k) K905520 · Synectics-Dantec
510(k) numberK905520
Submission
- Device name
- Microtrapper/Microdigitrapper, Modification
- Applicant
- Synectics-Dantec
Irving, TX, US - Received
- December 7, 1990
- Decision date
- April 26, 1991
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K961346 | PH Analysis ModuleFFT · Traditional | 01/29/1997SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | 09/30/1994SE |
| K924875 | Microtrapper/Microdigitrapper, Add ModificationsBZQ · Traditional | 06/30/1994ST |
| K914793 | Monocrystant Ph/Les Catheter, ModificationKLA · Traditional | 12/13/1993SE |
| 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 |
| K914219 | Airway ThermistorBZG · Traditional | 02/26/1992SE |
| K913387 | Digitrapper Mark IIIFFT · Traditional | 12/27/1991SE |
| K904625 | Synectics Liberty System, PC Polygraf and PolygramBZG · Traditional | 08/20/1991SE |
Questions and answers
When was Microtrapper/Microdigitrapper, Modification cleared by the FDA?
Microtrapper/Microdigitrapper, Modification (K905520) received a 510(k) decision of Substantially Equivalent on April 26, 1991, 140 days after the submission was received.
What is the product code of K905520?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.