The following data is part of a premarket notification filed by A&d Medical Div. with the FDA for A&d Medical Tm-2430 And Tm-2431 Ambulatory Blood Pressure.
Device ID | K992808 |
510k Number | K992808 |
Device Name: | A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A&D MEDICAL DIV. 1555 MCCANDLESS DR. Milpitas, CA 95025 |
Contact | Jerry Wang |
Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1999-08-20 |
Decision Date | 1999-09-01 |