Masterscreen Ios
FDA 510(k) K101873 · Carefusion Germany 234 GmbH
510(k) numberK101873
Submission
- Device name
- Masterscreen Ios
- Applicant
- Carefusion Germany 234 GmbH
Hoechberg, DE - Received
- July 6, 2010
- Decision date
- February 10, 2011
- 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 Masterscreen Ios cleared by the FDA?
Masterscreen Ios (K101873) received a 510(k) decision of Substantially Equivalent on February 10, 2011, 219 days after the submission was received.
What is the product code of K101873?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.