Multimed (TM) Pulmonary Function Testing System
FDA 510(k) K895414 · Integrated Medical Systems, Inc.
510(k) numberK895414
Submission
- Device name
- Multimed (TM) Pulmonary Function Testing System
- Applicant
- Integrated Medical Systems, Inc.
Golden, CO, US - Received
- September 1, 1989
- Decision date
- February 12, 1990
- 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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| 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 |
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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 |
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|---|---|---|
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| K902682 | Stick-Gard Sterile CapLDQ · Traditional | 09/26/1990SE |
| K871659 | IMS-2000S Stress MonitorDXG · Traditional | 05/28/1987SE |
| K870934 | IMS-2000R Resting Electrocardiographic SystemDXG · Traditional | 05/06/1987SE |
Questions and answers
When was Multimed (TM) Pulmonary Function Testing System cleared by the FDA?
Multimed (TM) Pulmonary Function Testing System (K895414) received a 510(k) decision of Substantially Equivalent on February 12, 1990, 164 days after the submission was received.
What is the product code of K895414?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.