K955482 is an FDA 510(k) clearance for the SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION). This device is classified as a Hood, Oxygen, Infant (Class I - General Controls, product code FOG).
Submitted by Advantage Medical Services, Inc. (Edgerton, US). The FDA issued a Cleared decision on January 30, 1996, 90 days after receiving the submission on November 1, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.
| 510(k) Number | K955482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1995 |
| Decision Date | January 30, 1996 |
| Days to Decision | 90 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 |