The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelab Model 90845 Pcms Multidisclosure Station.
| Device ID | K913038 |
| 510k Number | K913038 |
| Device Name: | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Raymond W.gifford |
| Correspondent | Raymond W.gifford 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 | 1991-07-09 |
| Decision Date | 1991-10-04 |