The following data is part of a premarket notification filed by Biological Signal Processing Ltd. with the FDA for Hyperq Ad-100 System.
Device ID | K102579 |
510k Number | K102579 |
Device Name: | HYPERQ AD-100 SYSTEM |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | BIOLOGICAL SIGNAL PROCESSING LTD. 291 Hillside Avenue Somerset, MA 02726 |
Contact | George J Hattub |
Correspondent | George J Hattub BIOLOGICAL SIGNAL PROCESSING LTD. 291 Hillside Avenue Somerset, MA 02726 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-08 |
Decision Date | 2010-12-02 |
Summary: | summary |