The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs P.c. Cardiac Output/pressure Module.
| Device ID | K860689 |
| 510k Number | K860689 |
| Device Name: | SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE |
| Classification | Computer, Blood-pressure |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Hans, P.e. |
| Correspondent | Hans, P.e. SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-25 |
| Decision Date | 1986-07-30 |