The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Series 90700 Patient Monitors.
Device ID | K862951 |
510k Number | K862951 |
Device Name: | SPACELABS SERIES 90700 PATIENT MONITORS |
Classification | Electrocardiograph |
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 | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-05 |
Decision Date | 1986-09-23 |