The following data is part of a premarket notification filed by Ashai Co. Ltd. with the FDA for Oxy-two.
| Device ID | K852624 |
| 510k Number | K852624 |
| Device Name: | OXY-TWO |
| Classification | Mask, Oxygen |
| Applicant | ASHAI CO. LTD. 620 HARRIS ST. ULTIMO, N.S.W. 2007 Australia, AU |
| Contact | Kalnin |
| Correspondent | Kalnin ASHAI CO. LTD. 620 HARRIS ST. ULTIMO, N.S.W. 2007 Australia, AU |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-20 |
| Decision Date | 1985-09-18 |