NHK · Resuscitator, Manual, Non Self-Inflating
Anesthesiology · 21 CFR 868.5905 · Class 2
Overview
| Product Code | NHK |
|---|---|
| Device Name | Resuscitator, Manual, Non Self-Inflating |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Classification Rationale
Class II (performance standards).
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092687 | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER | A Plus Medical | Nov 23, 2009 | SESE |
| K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | Ventlab Corp. | Feb 11, 2002 | SESE |
| K013308 | VENTLAB HYPERINFLATION BAG SYSTEM | Ventlab Corp. | Dec 20, 2001 | SESE |
| K001714 | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | Mercury Medical | Nov 3, 2000 | SESE |
| K970785 | SIMS HYPERINFLATION BAG SYSTEM | Sims | Jun 13, 1997 | SESE |
| K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | Intertech Resources, Inc. | Jun 8, 1995 | SESE |
| K942571 | HYPER-INFLATION BAG | Med-Plastics Intl., Inc. | Jun 10, 1994 | SESE |
| K940255 | HYPERINFLATION BAG SYSTEM | Nutec, Inc. | Feb 17, 1994 | SESE |
| K894612 | INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM | Intertech Resources, Inc. | Sep 8, 1989 | SESE |
| K813317 | DISP. HYPERINFLATION BAG SYSTEM | Intec Medical, Inc. | Mar 12, 1982 | SESE |
Top Applicants
- Ventlab Corp. — 2 clearances
- Intertech Resources, Inc. — 2 clearances
- Sims — 1 clearance
- Nutec, Inc. — 1 clearance
- Mercury Medical — 1 clearance
