510(k) K090722
K090722 is an FDA 510(k) premarket notification submitted by Shape Medical Systems, Inc. for the device "SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 2009. 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
- March 31, 2009
- Date Received
- March 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type