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 |