K001714 is an FDA 510(k) clearance for the MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149. This device is classified as a Resuscitator, Manual, Non Self-inflating (Class II - Special Controls, product code NHK).
Submitted by Mercury Medical (Clearwater, US). The FDA issued a Cleared decision on November 3, 2000, 151 days after receiving the submission on June 5, 2000.
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 | K001714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2000 |
| Decision Date | November 03, 2000 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| 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. |