Who is the manufacturer of RESPIEVENTS?

Non-Invasive Monitoring Systems, Inc. submitted the Traditional clearance for RESPIEVENTS (K942771).

What is the FDA product code for RESPIEVENTS?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for RESPIEVENTS?

510(k) clearance (submission type: Traditional).

RESPIEVENTS

K942771 · Non-Invasive Monitoring Systems, Inc. · DQK · Feb 13, 1996 · Cardiovascular

Device Facts

Record ID	K942771
Device Name	RESPIEVENTS
Applicant	Non-Invasive Monitoring Systems, Inc.
Product Code	DQK · Cardiovascular
Decision Date	Feb 13, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.