Home / 510(k) Clearances / K150888

510(k) K150888

Shape-HF Cardiopulmonary Testing System by Shape Medical Systems, Inc. — Product Code BTY

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

Other clearances by Shape Medical Systems, Inc.

  • K090722 — SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM (March 31, 2009)

Other clearances for product code BTY

  • K242809 — Ascent Cardiorespiratory Diagnostic Software (October 17, 2024)
  • K223629 — SpiroSphere, SpiroSphereECG, CardioSphere (May 28, 2024)
  • K231561 — Pulmonary Function Tester, Model: A9 (February 21, 2024)
  • K222982 — Virtus Metabolic Monitor (June 23, 2023)
  • K221030 — Model 9100 PFT/DICO (July 15, 2022)
  • K202754 — MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (January 28, 2021)
  • K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (February 6, 2020)
  • K181912 — Ascent Cardiorespiratory Diagnostic Software (April 12, 2019)
  • K173937 — SpiroSphere (February 15, 2019)
  • K161534 — EasyOne Pro Respiratory Analysis System (February 22, 2017)