Disp. Hyperinflation Bag System
FDA 510(k) K813317 · Intec Medical, Inc.
510(k) numberK813317
Submission
- Device name
- Disp. Hyperinflation Bag System
- Applicant
- Intec Medical, Inc.
Blue Springs, MO, US - Received
- November 24, 1981
- Decision date
- March 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | 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 |
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| K903216 | The Guider Coronary Guiding CatheterDQY · Traditional | 10/19/1990SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | 10/19/1990SE |
| K903840 | Giant Lumen Safetip Series: Endomyocardial BiopsyDYB · Traditional | 10/16/1990SE |
| K903906 | Percutaneous Catheter Introducer KitDYB · Traditional | 09/26/1990SE |
| K900998 | Interventional Medical Y Adapter W/Adjust. ValveDQY · Traditional | 08/14/1990SE |
| K901247 | Tri Adapter W/Adjustable Hemostasis ValvesDYG · Traditional | 07/31/1990SE |
| K894925 | Amcath Ureteral Dilators Models 7100,7110,7120EZN · Traditional | 12/13/1989SE |
| K860941 | Disposable Heated Wire Loops 48 and 72BZE · Traditional | 04/02/1986SE |
Questions and answers
When was Disp. Hyperinflation Bag System cleared by the FDA?
Disp. Hyperinflation Bag System (K813317) received a 510(k) decision of Substantially Equivalent on March 12, 1982, 108 days after the submission was received.
What is the product code of K813317?
The FDA product code is NHK – Resuscitator, Manual, Non Self-Inflating, a Class II (moderate risk) device regulated under 21 CFR 868.5905.