The following data is part of a premarket notification filed by Pulse Biomedical, Inc. with the FDA for Qrs-card Cardiology Suite.
| Device ID | K042799 |
| 510k Number | K042799 |
| Device Name: | QRS-CARD CARDIOLOGY SUITE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | PULSE BIOMEDICAL, INC. 935 SOUTH TROOPER RD. Norristown, PA 19403 |
| Contact | Saleem Hasan |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-08 |
| Decision Date | 2004-10-22 |
| Summary: | summary |