510(k) K052328
K052328 is an FDA 510(k) premarket notification submitted by Zan Messgerate GmbH for the device "ZAN LUNG-FUNCTION LAB". The FDA issued a decision of Substantially Equivalent on December 22, 2005. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Zan Messgerate GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2005
- Date Received
- August 25, 2005
- Clearance Type
- Traditional
- 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