The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Advanced Nibp Module.
| Device ID | K982641 |
| 510k Number | K982641 |
| Device Name: | ADVANCED NIBP MODULE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
| Contact | Darlene T Korab |
| Correspondent | Darlene T Korab JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-29 |
| Decision Date | 1999-03-29 |
| Summary: | summary |