The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Electro Sensor Complex Software (es Complex Software).
Device ID | K113264 |
510k Number | K113264 |
Device Name: | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | LD TECHNOLOGY LLC 100 Biscayne Blvd Ste 502 Miami, FL 33132 |
Contact | Abbert Maarek |
Correspondent | Abbert Maarek LD TECHNOLOGY LLC 100 Biscayne Blvd Ste 502 Miami, FL 33132 |
Product Code | DXN |
Subsequent Product Code | DQA |
Subsequent Product Code | GZO |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-04 |
Decision Date | 2012-03-02 |
Summary: | summary |