SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM— 510(k) K090722
Substantially EquivalentShape Medical Systems, Inc.
FDA 510(k) clearance K090722 for SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM, Substantially Equivalent on 2009-03-31. Applicant: Shape Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Shape Medical Systems, Inc.
- Product code
- Code BTY
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code BTY
view allMore clearances from Shape Medical Systems, Inc.
view allRecalls naming K090722
K-number listed on FDA's recall record- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090722.
Data sourced from openFDA. This site is unofficial and independent of the FDA.