510(k) K082539
K082539 is an FDA 510(k) premarket notification submitted by Cardinal Health Germany 234 GmbH for the device "MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT". The FDA issued a decision of Substantially Equivalent on December 2, 2008. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Cardinal Health Germany 234 GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2008
- Date Received
- September 2, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type