NHK — Resuscitator, Manual, Non Self-Inflating Class II
FDA product code NHK covers "Resuscitator, Manual, Non Self-Inflating", a Class II medical device regulated under 21 CFR 868.5905. Submissions are reviewed by the Anesthesiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
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 |