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 |