NHK — Resuscitator, Manual, Non Self-Inflating Class II
Classification Details
- Product Code
- NHK
- Device Class
- Class II
- Regulation Number
- 868.5905
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K092687 | a plus medical | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER | November 23, 2009 |
| K020281 | ventlab | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | February 11, 2002 |
| K013308 | ventlab | VENTLAB HYPERINFLATION BAG SYSTEM | December 20, 2001 |
| K001714 | mercury medical | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | November 3, 2000 |
| K970785 | sims | SIMS HYPERINFLATION BAG SYSTEM | June 13, 1997 |
| K952214 | intertech resources | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | June 8, 1995 |
| K942571 | med-plastics intl | HYPER-INFLATION BAG | June 10, 1994 |
| K940255 | nutec | HYPERINFLATION BAG SYSTEM | February 17, 1994 |
| K894612 | intertech resources | INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM | September 8, 1989 |
| K813317 | intec medical | DISP. HYPERINFLATION BAG SYSTEM | March 12, 1982 |