The following data is part of a premarket notification filed by Biological Signal Processing Ltd. with the FDA for Hyperq System.
| Device ID | K070624 |
| 510k Number | K070624 |
| Device Name: | HYPERQ 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 | 2007-03-06 |
| Decision Date | 2007-04-06 |
| Summary: | summary |