The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Markii Ventimasks.
| Device ID | K781325 |
| 510k Number | K781325 |
| Device Name: | MARKII VENTIMASKS |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-01 |
| Decision Date | 1978-09-27 |