510(k) K101873
K101873 is an FDA 510(k) premarket notification submitted by Carefusion Germany 234 GmbH for the device "MASTERSCREEN IOS". The FDA issued a decision of Substantially Equivalent on February 10, 2011. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Carefusion Germany 234 GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2011
- Date Received
- July 6, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type