510(k) K040698
K040698 is an FDA 510(k) premarket notification submitted by Viasys Healthcare GmbH for the device "MASTERSCREEN CPX AND OXYCON CPX". The FDA issued a decision of Substantially Equivalent on April 7, 2004. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Viasys Healthcare GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2004
- Date Received
- March 17, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type