The following data is part of a premarket notification filed by Ann Arbor Plastics, Inc. with the FDA for Oxygen Hoods.
| Device ID | K791861 |
| 510k Number | K791861 |
| Device Name: | OXYGEN HOODS |
| Classification | Hood, Oxygen, Infant |
| Applicant | ANN ARBOR PLASTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FOG |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-24 |
| Decision Date | 1979-10-04 |