Synectics Liberty System, PC Polygraf and Polygram
FDA 510(k) K904625 · Synectics-Dantec
510(k) numberK904625
Submission
- Device name
- Synectics Liberty System, PC Polygraf and Polygram
- Applicant
- Synectics-Dantec
Sweden, SE - Received
- October 10, 1990
- Decision date
- August 20, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
| K230501 | Spirobank OxiBZG · Traditional | Mir Medical International Research USA | 12/15/2023SE |
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| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
| K222443 | Air Smart Extra SpirometerBZG · Traditional | Feellife Health, Inc. | 08/09/2023SE |
| K213754 | SpiroHome Personal, SpiroHome ClinicBZG · Traditional | Inofab Saglik Teknolojileri A.S | 06/12/2023SE |
| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
More from Vitalograph Ireland, Ltd.
| 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 |
| K905520 | Microtrapper/Microdigitrapper, ModificationBZQ · Traditional | 04/26/1991SE |
Questions and answers
When was Synectics Liberty System, PC Polygraf and Polygram cleared by the FDA?
Synectics Liberty System, PC Polygraf and Polygram (K904625) received a 510(k) decision of Substantially Equivalent on August 20, 1991, 314 days after the submission was received.
What is the product code of K904625?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.