The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Patient Care Management System Modification.
Device ID | K910029 |
510k Number | K910029 |
Device Name: | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION |
Classification | Echocardiograph |
Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Contact | Raymond Gifford |
Correspondent | Raymond Gifford SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Product Code | DXK |
CFR Regulation Number | 870.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-03 |
Decision Date | 1991-01-31 |