The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Medical Casemaster Information Management System.
| Device ID | K951605 |
| 510k Number | K951605 |
| Device Name: | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Russ Garrison |
| Correspondent | Russ Garrison SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-07-14 |