The following data is part of a premarket notification filed by Vitalab Products Corp. with the FDA for Mask, Oxygen, Nonbreathing.
| Device ID | K781414 |
| 510k Number | K781414 |
| Device Name: | MASK, OXYGEN, NONBREATHING |
| Classification | Mask, Oxygen, Non-rebreathing |
| Applicant | VITALAB PRODUCTS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KGB |
| CFR Regulation Number | 868.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-15 |
| Decision Date | 1978-09-07 |