Aerosure Medic
FDA 510(k) K140772 · Actegy , Ltd.
510(k) numberK140772
Submission
- Device name
- Aerosure Medic
- Applicant
- Actegy , Ltd.
Washington, DC, US - Received
- March 27, 2014
- Decision date
- December 19, 2014
- 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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| K152480 | Revitive Medic; Revitive MV; Revitive LVNGX · Traditional | 03/31/2016SE |
| K143207 | Revitive IX (OTC)NGX · Traditional | 03/23/2015SE |
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Questions and answers
When was Aerosure Medic cleared by the FDA?
Aerosure Medic (K140772) received a 510(k) decision of Substantially Equivalent on December 19, 2014, 267 days after the submission was received.
What is the product code of K140772?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.