EZ-1 System Respiratory Effort Sensors
FDA 510(k) K913395 · Pro-Tech, Inc.
510(k) numberK913395
Submission
- Device name
- EZ-1 System Respiratory Effort Sensors
- Applicant
- Pro-Tech, Inc.
Woodinville, WA, US - Received
- July 30, 1991
- Decision date
- May 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K940013 | Body Position Indicator, Model BPI1MNR · Traditional | 05/04/1995SE |
| K940015 | Snoring Microphone, SM1MNR · Traditional | 01/11/1995SE |
| K940014 | PLM Sensor, Model PLM1BZQ · Traditional | 11/10/1994ST |
| K924752 | Freedom Oximeter/Eeg Digital InterfaceDQA · Traditional | 09/10/1993SE |
| K923402 | Crystal Trace Piezo Respiratory Effort SensorBZQ · Traditional | 12/30/1992SE |
| K913396 | Cannula Style ThermocouplesBZG · Traditional | 05/22/1992SE |
Questions and answers
When was EZ-1 System Respiratory Effort Sensors cleared by the FDA?
EZ-1 System Respiratory Effort Sensors (K913395) received a 510(k) decision of Substantially Equivalent on May 20, 1992, 295 days after the submission was received.
What is the product code of K913395?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.