Shape Medical Systems, Inc.
Shape Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2016, with 2 FDA device recalls on record.
Top product codes for Shape Medical Systems, Inc.
FDA recalls by Shape Medical Systems, Inc.
- Z-1060-2015 — Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
- Z-2051-2014 — Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Shape Medical Systems, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.