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 |