The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A & D Medicallifesource Us-779pc & Ua-779t Digital Blood Pressure Monitors.
Device ID | K993888 |
510k Number | K993888 |
Device Name: | A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
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 | 1999-11-16 |
Decision Date | 1999-12-20 |