Resuscitator, Manual, Non Self-Inflating
FDA product code NHK · Class II (moderate risk) · 21 CFR 868.5905 · Anesthesiology
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.
10510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092687 | Venti.Plus Hyperinflation Bag System with Pressure ManometerNHK · Traditional | A Plus Medical | 11/23/2009SE |
| K020281 | Modification to Ventlab Hyperinflation Bag SystemNHK · Special | Ventlab Corp. | 02/11/2002SE |
| K013308 | Ventlab Hyperinflation Bag SystemNHK · Traditional | Ventlab Corp. | 12/20/2001SE |
| K001714 | Mercury Medical Hyperinflation Bag System, Model 83-900-0149NHK · Traditional | Mercury Medical | 11/03/2000SE |
| K970785 | Sims Hyperinflation Bag SystemNHK · Traditional | Sims | 06/13/1997SE |
| K952214 | Sims Intertech Hyperinflation Bag SystemNHK · Traditional | Intertech Resources, Inc. | 06/08/1995SE |
| K942571 | Hyper-Inflation BagNHK · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K940255 | Hyperinflation Bag SystemNHK · Traditional | Nutec, Inc. | 02/17/1994SE |
| K894612 | Intertech Newborn Hyperinflation Bag SystemNHK · Traditional | Intertech Resources, Inc. | 09/08/1989SE |
| K813317 | Disp. Hyperinflation Bag SystemNHK · Traditional | Intec Medical, Inc. | 03/12/1982SE |