K791861 is an FDA 510(k) clearance for the OXYGEN HOODS. This device is classified as a Hood, Oxygen, Infant (Class I - General Controls, product code FOG).
Submitted by Ann Arbor Plastics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979, 10 days after receiving the submission on September 24, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.
| 510(k) Number | K791861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1979 |
| Decision Date | October 04, 1979 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | FOG — Hood, Oxygen, Infant |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5700 |