The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Heart Rate Variability Software Option.
Device ID | K950779 |
510k Number | K950779 |
Device Name: | HEART RATE VARIABILITY SOFTWARE OPTION |
Classification | Electrocardiograph |
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 | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-21 |
Decision Date | 1995-04-25 |