Cleared Traditional

COSMED QUARK

K001174 · Cosmed Srl · Anesthesiology
Jan 2001
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K001174 is an FDA 510(k) clearance for the COSMED QUARK, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on January 11, 2001, 275 days after receiving the submission on April 11, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K001174 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2000
Decision Date January 11, 2001
Days to Decision 275 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZC — Calculator, Pulmonary Function Data
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1880

Similar Devices — BZC Calculator, Pulmonary Function Data

All 89
STS
K240293 · Techbopulm, Ltd. · Sep 2024
Vyntus/SentrySuite Product Line
K183567 · Vyaire Medical · Aug 2019
Vyntus BODY
K190853 · Vyaire Medical, Inc. · Aug 2019
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
K181524 · Vyaire Medical, Inc. · Nov 2018
COSMED K5 Wearable Metabolic Technology
K162515 · Cosmed Srl · Jun 2017
MiniBox +
K161295 · Pulmone Advanced Medical Devices, Ltd. · Oct 2016