The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Micro Fd 7000 Ambulatory Blood Pressure Monitor.
Device ID | K896102 |
510k Number | K896102 |
Device Name: | MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | ADVANCED MEDICAL PRODUCTS, INC. 4709 CROSSROADS PARK DR. Liverpool, NY 13088 |
Contact | Kevin M Wortel |
Correspondent | Kevin M Wortel ADVANCED MEDICAL PRODUCTS, INC. 4709 CROSSROADS PARK DR. Liverpool, NY 13088 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-23 |
Decision Date | 1990-01-18 |