Spirometer, Model TS-1000, Part No. SLZ7504
FDA 510(k) K860522 · Teledyne Avionics Div. of Teledyne
510(k) numberK860522
Submission
- Device name
- Spirometer, Model TS-1000, Part No. SLZ7504
- Applicant
- Teledyne Avionics Div. of Teledyne
Charlottesville, VA, US - Received
- February 11, 1986
- Decision date
- March 3, 1986
- 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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|---|---|---|---|
| K251777 | MESI mTABLET SPIROBZG · Traditional | Mesi D.O.O. | 03/02/2026SE |
| K241843 | TD-7301 Spirometer (TD-7301)BZG · Traditional | Gostar Co., Ltd. | 11/20/2024SE |
| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
| K230501 | Spirobank OxiBZG · Traditional | Mir Medical International Research USA | 12/15/2023SE |
| K230178 | EasyOne Sky SpirometerBZG · Traditional | Ndd Medizintechnik AG | 10/19/2023SE |
| 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 |
|---|---|---|
| K860262 | TA-6C - Part Number SLZ 7520ETY · Traditional | 04/23/1986SE |
| K855068 | Spirometer, Model TS-500 Part #SLZ7534BTY · Traditional | 02/05/1986SE |
| K855070 | Spirometer Model TS-200 SLZ 7541BZC · Traditional | 01/30/1986SE |
| K855069 | Spirometer TS-400 SLZ 7547BTY · Traditional | 01/30/1986SE |
| K854043 | Automatic Impedance Audiometer, TA-7BETY · Traditional | 12/31/1985SE |
| K851015 | TA-20 Automatic Industiral AudiometerEWO · Traditional | 06/04/1985SE |
| K850461 | Automatic Impedance Meter TA-7AETY · Traditional | 03/25/1985SE |
| K844069 | TA-201 Clinical AudiometerEWO · Traditional | 12/03/1984SE |
| K811509 | Auto-Tympanigraph (TA-5A)ETY · Traditional | 06/16/1981SE |
| K801325 | Clinical Audiometer Model TA-200EWO · Traditional | 06/30/1980SE |
Questions and answers
When was Spirometer, Model TS-1000, Part No. SLZ7504 cleared by the FDA?
Spirometer, Model TS-1000, Part No. SLZ7504 (K860522) received a 510(k) decision of Substantially Equivalent on March 3, 1986, 20 days after the submission was received.
What is the product code of K860522?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.