The following data is part of a premarket notification filed by Vitalab Products Corp. with the FDA for Mask, Pxygen.
| Device ID | K781413 |
| 510k Number | K781413 |
| Device Name: | MASK, PXYGEN |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | VITALAB PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-15 |
| Decision Date | 1978-09-07 |