K942571 is an FDA 510(k) clearance for the HYPER-INFLATION BAG. This device is classified as a Resuscitator, Manual, Non Self-inflating (Class II - Special Controls, product code NHK).
Submitted by Med-Plastics Intl., Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 10, 1994, 10 days after receiving the submission on May 31, 1994.
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 | K942571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1994 |
| Decision Date | June 10, 1994 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| 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. |