K894612 is an FDA 510(k) clearance for the INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM. This device is classified as a Resuscitator, Manual, Non Self-inflating (Class II - Special Controls, product code NHK).
Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on September 8, 1989, 50 days after receiving the submission on July 20, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905. 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..
| 510(k) Number | K894612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1989 |
| Decision Date | September 08, 1989 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | NHK — Resuscitator, Manual, Non Self-inflating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |
| 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. |