The following data is part of a premarket notification filed by Pulse Biomedical, Inc. with the FDA for Qrs Card S-t Segment Analysis Patient Monitoring System Model: Qrs Card Usb.
| Device ID | K100813 |
| 510k Number | K100813 |
| Device Name: | QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB |
| Classification | Electrocardiograph |
| Applicant | PULSE BIOMEDICAL, INC. 1305 CATFISH LANE Norristown, PA 19403 |
| Contact | Saleem Hasan |
| Correspondent | Saleem Hasan PULSE BIOMEDICAL, INC. 1305 CATFISH LANE Norristown, PA 19403 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-23 |
| Decision Date | 2010-07-23 |
| Summary: | summary |