The following data is part of a premarket notification filed by Pulse Biomedical, Inc. with the FDA for Pulse Biomedical Inc, Qrs Card S-t Segment Analysis Monitoring System.
| Device ID | K972255 |
| 510k Number | K972255 |
| Device Name: | PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | PULSE BIOMEDICAL, INC. 935 SOUTH TROOPER RD. Norristown, PA 19403 |
| Contact | Saleem Hasan |
| Correspondent | Saleem Hasan PULSE BIOMEDICAL, INC. 935 SOUTH TROOPER RD. Norristown, PA 19403 |
| Product Code | LOS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-17 |
| Decision Date | 1998-07-07 |