The following data is part of a premarket notification filed by Micro Weiss Electronics with the FDA for Microlife Automatic Blood Pressure Monitor.
Device ID | K970211 |
510k Number | K970211 |
Device Name: | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | MICRO WEISS ELECTRONICS 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk MICRO WEISS ELECTRONICS 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-21 |
Decision Date | 1998-04-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00634782553173 | K970211 | 000 |