Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Shape-HF Cardiopulmonary Testing System

K-Number: K150888 · 2016-01-21

ApplicantShape Medical Systems, Inc.
Decision Date2016-01-21
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Shape-HF Cardiopulmonary Testing System is a medical device manufactured by Shape Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-01-21 under approval number K150888. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shape-HF Cardiopulmonary Testing System?

Shape-HF Cardiopulmonary Testing System is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Shape Medical Systems, Inc.. The 510(k) number is K150888.

When was Shape-HF Cardiopulmonary Testing System approved by the FDA?

Shape-HF Cardiopulmonary Testing System received FDA 510(k) clearance on 2016-01-21, under approval number K150888.

What company makes Shape-HF Cardiopulmonary Testing System?

Shape-HF Cardiopulmonary Testing System is manufactured by Shape Medical Systems, Inc..

What is the FDA product code for Shape-HF Cardiopulmonary Testing System?

The FDA product code for Shape-HF Cardiopulmonary Testing System is BTY.

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025) PMID: 40058872 Monocyte activation test (MAT) as an ethical alternative to animal testing. BMB reports (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Related Devices (Code: BTY)

K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG K181912Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation K173937SpiroSphereEresearchtechnology GmbH K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑