Aerobika Positive Expiratory Pressure Device
FDA 510(k) K123400 · Trudell Medical Intl.
510(k) numberK123400
Submission
- Device name
- Aerobika Positive Expiratory Pressure Device
- Applicant
- Trudell Medical Intl.
London, CA - Received
- November 5, 2012
- Decision date
- May 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-Vu Inspiratory Flow…NVP · Special | 04/11/2007SE |
| K053605 | Aeroeclipse II Breath Actuated NebulizerCAF · Special | 02/27/2006SE |
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Questions and answers
When was Aerobika Positive Expiratory Pressure Device cleared by the FDA?
Aerobika Positive Expiratory Pressure Device (K123400) received a 510(k) decision of Substantially Equivalent on May 16, 2013, 192 days after the submission was received.
What is the product code of K123400?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.