Cleared Traditional

COSMED MICROQUARK

K020745 · Cosmed Srl · Anesthesiology
Jan 2003
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K020745 is an FDA 510(k) clearance for the COSMED MICROQUARK, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on January 2, 2003, 301 days after receiving the submission on March 7, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K020745 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2002
Decision Date January 02, 2003
Days to Decision 301 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTY — Calculator, Predicted Values, Pulmonary Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890

Similar Devices — BTY Calculator, Predicted Values, Pulmonary Function

All 62
Ascent Cardiorespiratory Diagnostic Software
K242809 · Medical Graphics Corporation · Oct 2024
SpiroSphere, SpiroSphereECG, CardioSphere
K223629 · Eresearchtechnology GmbH · May 2024
Pulmonary Function Tester, Model: A9
K231561 · Guangzhou Homesun Medical Technology Co., Ltd. · Feb 2024
Virtus Metabolic Monitor
K222982 · Virtus Technology Aps · Jun 2023
Model 9100 PFT/DICO
K221030 · Vitalograph (Ireland) , Ltd. · Jul 2022
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
K202754 · Eresearchtechnology GmbH · Jan 2021