Microblab, Microloop
FDA 510(k) K141936 · Carefusion Germany 234 GmbH
510(k) numberK141936
Submission
- Device name
- Microblab, Microloop
- Applicant
- Carefusion Germany 234 GmbH
Hoechberg, DE - Received
- July 17, 2014
- Decision date
- December 29, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Microblab, Microloop cleared by the FDA?
Microblab, Microloop (K141936) received a 510(k) decision of Substantially Equivalent on December 29, 2014, 165 days after the submission was received.
What is the product code of K141936?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.