EMS Pulmonary Function Testing Filter
FDA 510(k) K013123 · Engineered Medical Systems
510(k) numberK013123
Submission
- Device name
- EMS Pulmonary Function Testing Filter
- Applicant
- Engineered Medical Systems
Mccordsville, IN, US - Received
- September 19, 2001
- Decision date
- March 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
|---|---|---|
| K220533 | Endoscopy Oxygen MaskCCK · Traditional | 11/16/2022SE |
| K062104 | Talking TrachBTO · Traditional | 04/20/2007SE |
| K023683 | Multi-Strap Full Face MaskBZD · Traditional | 12/01/2003SE |
| K013728 | Trach VoxJOH · Traditional | 07/30/2002SE |
| K013122 | EMS Electrostatic Fliter and Hme CombinationCAH · Traditional | 04/19/2002SE |
| K013089 | EMS Hepa Filter and Hme CombinationsCAH · Traditional | 03/14/2002SE |
| K003497 | Disposable Pressure MonitorCAP · Traditional | 11/30/2000SE |
| K000215 | Swivel ElbowBZD · Traditional | 05/26/2000SE |
| K000314 | Incentive SpirometerBWF · Traditional | 04/12/2000SE |
| K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…BTM · Traditional | 07/06/1999SE |
Questions and answers
When was EMS Pulmonary Function Testing Filter cleared by the FDA?
EMS Pulmonary Function Testing Filter (K013123) received a 510(k) decision of Substantially Equivalent on March 14, 2002, 176 days after the submission was received.
What is the product code of K013123?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.