The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Model 1888 Alpha Cos/respiration Car.
| Device ID | K834460 |
| 510k Number | K834460 |
| Device Name: | MODEL 1888 ALPHA COS/RESPIRATION CAR |
| Classification | Legging, Compression, Non-inflatable |
| Applicant | SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LLK |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-19 |
| Decision Date | 1984-02-13 |