The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Vaporizer Spacer.
| Device ID | K860545 |
| 510k Number | K860545 |
| Device Name: | VAPORIZER SPACER |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada, CA L4m 5r4 |
| Contact | Lee Mcdonald |
| Correspondent | Lee Mcdonald SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada, CA L4m 5r4 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-13 |
| Decision Date | 1986-04-17 |