Asthma Monitor AM3
FDA 510(k) K092890 · Carefusion Germany 234 GmbH
510(k) numberK092890
Submission
- Device name
- Asthma Monitor AM3
- Applicant
- Carefusion Germany 234 GmbH
Hoechberg, DE - Received
- September 21, 2009
- Decision date
- January 13, 2010
- 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 AM3 cleared by the FDA?
Asthma Monitor AM3 (K092890) received a 510(k) decision of Substantially Equivalent on January 13, 2010, 114 days after the submission was received.
What is the product code of K092890?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.