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510(k) K881122

UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. by Medical Associated Services, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1988
Date Received
March 16, 1988
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 Medical Associated Services, Inc.

  • K921178 — PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (August 26, 1992)
  • K903939 — PANDA HELIUM GAS ANALYZER (January 3, 1991)
  • K893845 — PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM (October 27, 1989)
  • K883008 — PULMONARY FORCED FLOW SYSTEM (PUFFS) (September 29, 1988)
  • K864087 — PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM (November 7, 1986)

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)