The following data is part of a premarket notification filed by Biological Signal Processing Ltd. with the FDA for Hyperq System.
| Device ID | K042981 |
| 510k Number | K042981 |
| Device Name: | HYPERQ SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | BIOLOGICAL SIGNAL PROCESSING LTD. 20 HATA'AS ST Kfar Saba, IL 44425 |
| Contact | Arava Hacohen |
| Correspondent | Arava Hacohen BIOLOGICAL SIGNAL PROCESSING LTD. 20 HATA'AS ST Kfar Saba, IL 44425 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-29 |
| Decision Date | 2005-03-10 |
| Summary: | summary |