The following data is part of a premarket notification filed by Nascor Pty. Ltd. with the FDA for Nascor Igloo.
| Device ID | K935126 |
| 510k Number | K935126 |
| Device Name: | NASCOR IGLOO |
| Classification | Tent, Oxygen |
| Applicant | NASCOR PTY. LTD. P.O. BOX 141 BEVERLY HILLS NSW Sydney Nsw, AU 2209 |
| Contact | Howard Chilton, M.d. |
| Correspondent | Howard Chilton, M.d. NASCOR PTY. LTD. P.O. BOX 141 BEVERLY HILLS NSW Sydney Nsw, AU 2209 |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-10-18 |