K962182 is an FDA 510(k) clearance for the BURLEW INFANT HOOD. This device is classified as a Hood, Oxygen, Infant (Class I — General Controls, product code FOG).
Submitted by Promedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on July 15, 1996, 39 days after receiving the submission on June 6, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.
| 510(k) Number | K962182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1996 |
| Decision Date | July 15, 1996 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | FOG — Hood, Oxygen, Infant |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5700 |