510(k) K091412
K091412 is an FDA 510(k) premarket notification submitted by Viasys Healthcare GmbH for the device "CLEAN PEAK FLOW METER". The FDA issued a decision of Substantially Equivalent on August 21, 2009. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Viasys Healthcare GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2009
- Date Received
- May 13, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Peak Flow, Spirometry
- Device Class
- Class II
- Regulation Number
- 868.1860
- Review Panel
- AN
- Submission Type