510(k) K091428
K091428 is an FDA 510(k) premarket notification submitted by Ndd Medizitechnik AG for the device "EASYONE PRO RESPIRATORY ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 27, 2010. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Ndd Medizitechnik AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2010
- Date Received
- May 14, 2009
- 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