The following data is part of a premarket notification filed by Mabis Healthcare, Inc. with the FDA for Mabis Brand And Mabis Customers Private Label Brand.
| Device ID | K942072 |
| 510k Number | K942072 |
| Device Name: | MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MABIS HEALTHCARE, INC. 28401 N. BALLARD DR. UNIT H Lake Forest, IL 60045 |
| Contact | Michael A Mazza |
| Correspondent | Michael A Mazza MABIS HEALTHCARE, INC. 28401 N. BALLARD DR. UNIT H Lake Forest, IL 60045 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1995-05-10 |