Sims Intertech Hyperinflation Bag System
FDA 510(k) K952214 · Intertech Resources, Inc.
510(k) numberK952214
Submission
- Device name
- Sims Intertech Hyperinflation Bag System
- Applicant
- Intertech Resources, Inc.
Fort Myers, FL, US - Received
- May 11, 1995
- Decision date
- June 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
More from Intec Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961318 | 1ST Response Disposable ManometerCAP · Traditional | 12/17/1996SE |
| K955008 | Heat & Moisture ExchangerBYD · Traditional | 01/30/1996SE |
| K953580 | Heat Moisture ExchangerBYD · Traditional | 09/15/1995SE |
| K952223 | Xenon Gas Breathing CircuitIYT · Traditional | 08/11/1995SE |
| K952169 | Safe Response Mouth-To-Mask Resuscitator, PediatricBTM · Traditional | 06/08/1995SE |
| K952062 | PFT FilterCAH · Traditional | 06/08/1995SE |
| K935036 | Hepa Filtered Heat and Moisture ExchangerBYD · Traditional | 01/25/1994SESK |
| K930816 | Hepa Filtered HmeCAH · Traditional | 07/01/1993SE |
| K922479 | Disposable Anesthesia Breathing Circuit, ModifiedBZO · Traditional | 10/30/1992SE |
| K921624 | Disposable Volume Vent/Anesthesia Breath CircuitsBYH · Traditional | 06/30/1992SE |
Questions and answers
When was Sims Intertech Hyperinflation Bag System cleared by the FDA?
Sims Intertech Hyperinflation Bag System (K952214) received a 510(k) decision of Substantially Equivalent on June 8, 1995, 28 days after the submission was received.
What is the product code of K952214?
The FDA product code is NHK – Resuscitator, Manual, Non Self-Inflating, a Class II (moderate risk) device regulated under 21 CFR 868.5905.