The following data is part of a premarket notification filed by Coast Medical, Inc. with the FDA for Gas Sampling Interfaces.
| Device ID | K943110 |
| 510k Number | K943110 |
| Device Name: | GAS SAMPLING INTERFACES |
| Classification | Tubing, Pressure And Accessories |
| Applicant | COAST MEDICAL, INC. 1060-H NORTH BATAVIA Orange, CA 92867 |
| Contact | Douglas R Mongeon |
| Correspondent | Douglas R Mongeon COAST MEDICAL, INC. 1060-H NORTH BATAVIA Orange, CA 92867 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1994-08-19 |