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 |