Hyperinflation Bag System

FDA 510(k) K940255 · Nutec, Inc.

Substantially Equivalent

510(k) numberK940255

Submission

Device name
Hyperinflation Bag System
Applicant
Nutec, Inc.
Winfield, IL, US
Received
January 19, 1994
Decision date
February 17, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NHK – Resuscitator, Manual, Non Self-Inflating
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5905
Specialty
Anesthesiology
Life-sustaining
Yes

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

Other 510(k)s with product code NHK

510(k)DeviceApplicantDecision
K092687Venti.Plus Hyperinflation Bag System with Pressure ManometerNHK · Traditional A Plus Medical11/23/2009SE
K020281Modification to Ventlab Hyperinflation Bag SystemNHK · Special Ventlab Corp.02/11/2002SE
K013308Ventlab Hyperinflation Bag SystemNHK · Traditional Ventlab Corp.12/20/2001SE
K001714Mercury Medical Hyperinflation Bag System, Model 83-900-0149NHK · Traditional Mercury Medical11/03/2000SE
K970785Sims Hyperinflation Bag SystemNHK · Traditional Sims06/13/1997SE
K952214Sims Intertech Hyperinflation Bag SystemNHK · Traditional Intertech Resources, Inc.06/08/1995SE
K942571Hyper-Inflation BagNHK · Traditional Med-Plastics Intl., Inc.06/10/1994SE
K894612Intertech Newborn Hyperinflation Bag SystemNHK · Traditional Intertech Resources, Inc.09/08/1989SE
K813317Disp. Hyperinflation Bag SystemNHK · Traditional Intec Medical, Inc.03/12/1982SE

More from Intec Medical, Inc.

510(k)DeviceDecision
K940257Hand-Held NebulizerCAF · Traditional 10/13/1994SE
K935821Double Trach Swivel ConnectorBZA · Traditional 01/14/1994SE

Questions and answers

When was Hyperinflation Bag System cleared by the FDA?

Hyperinflation Bag System (K940255) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 29 days after the submission was received.

What is the product code of K940255?

The FDA product code is NHK – Resuscitator, Manual, Non Self-Inflating, a Class II (moderate risk) device regulated under 21 CFR 868.5905.