The following data is part of a premarket notification filed by Medicalgorithmics Sp Z.o.o. with the FDA for Medicalgorithmics Real-time Ecg Monitor And Arrhythmia Detector, Model Pocketecg.
| Device ID | K090037 |
| 510k Number | K090037 |
| Device Name: | MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICALGORITHMICS SP Z.O.O. 245 WEST 107TH STREET SUITE 11A New York, NY 10025 |
| Contact | Martin Jasinski |
| Correspondent | Martin Jasinski MEDICALGORITHMICS SP Z.O.O. 245 WEST 107TH STREET SUITE 11A New York, NY 10025 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-06 |
| Decision Date | 2009-05-22 |
| Summary: | summary |