The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Airway Adapter Set Series, No. 369014.
| Device ID | K860352 |
| 510k Number | K860352 |
| Device Name: | SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014 |
| Classification | Connector, Airway (extension) |
| Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Hans, P.e. |
| Correspondent | Hans, P.e. SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-30 |
| Decision Date | 1986-03-19 |