The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Ans1 Software.
Device ID | K140412 |
510k Number | K140412 |
Device Name: | ANS1 SOFTWARE |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | LD TECHNOLOGY LLC 100 Biscayne Blvd Ste 502 Miami, FL 33132 |
Contact | Albert Maarek |
Correspondent | Albert 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-18 |
Decision Date | 2014-05-22 |
Summary: | summary |