K124032 is an FDA 510(k) clearance for the METANEB. This device is classified as a Device, Positive Pressure Breathing, Intermittent (Class II - Special Controls, product code NHJ).
Submitted by Hill-Rom Services Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on April 25, 2013, 118 days after receiving the submission on December 28, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K124032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2012 |
| Decision Date | April 25, 2013 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NHJ — Device, Positive Pressure Breathing, Intermittent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |