The following data is part of a premarket notification filed by Inhal-o-tech Medical Plastic with the FDA for Mask, Bi Flo Nasal Oxygen.
| Device ID | K781741 |
| 510k Number | K781741 |
| Device Name: | MASK, BI FLO NASAL OXYGEN |
| Classification | Mask, Oxygen |
| Applicant | INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Spring, MO 64015 |
| Contact | J.w. Brown |
| Correspondent | J.w. Brown INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Spring, MO 64015 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-07 |
| Decision Date | 1978-12-01 |