Asthma Monitor Model, AM1
FDA 510(k) K090486 · Cardinal Health Germany 234 GmbH
510(k) numberK090486
Submission
- Device name
- Asthma Monitor Model, AM1
- Applicant
- Cardinal Health Germany 234 GmbH
Palm Springs, CA, US - Received
- February 25, 2009
- Decision date
- May 6, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Asthma Monitor Model, AM1 cleared by the FDA?
Asthma Monitor Model, AM1 (K090486) received a 510(k) decision of Substantially Equivalent on May 6, 2009, 70 days after the submission was received.
What is the product code of K090486?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.