510(k) K150888
K150888 is an FDA 510(k) premarket notification submitted by Shape Medical Systems, Inc. for the device "Shape-HF Cardiopulmonary Testing System". The FDA issued a decision of Substantially Equivalent on January 21, 2016. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Shape Medical Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2016
- Date Received
- April 2, 2015
- 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