The following data is part of a premarket notification filed by Smart Solutions Technologies Sl with the FDA for Ecg Recorder And Arrhythmia Detector.
| Device ID | K173461 |
| 510k Number | K173461 |
| Device Name: | ECG Recorder And Arrhythmia Detector |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Smart Solutions Technologies SL Calle Toronga 21, Local 1 Madrid, ES 28015 |
| Contact | Daniel Llorca |
| Correspondent | Nandini Murthy ENEM Consulting, LLC 556 Lowell Street Lexington, MA 02420 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-07 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437011759030 | K173461 | 000 |
| 08437011759023 | K173461 | 000 |
| 08437011759016 | K173461 | 000 |
| 08437011759078 | K173461 | 000 |