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 |