The following data is part of a premarket notification filed by King & Spalding with the FDA for Nais Wrist Blood Pressure Meter.
| Device ID | K942423 |
| 510k Number | K942423 |
| Device Name: | NAIS WRIST BLOOD PRESSURE METER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
| Contact | Edward Basile |
| Correspondent | Edward Basile KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1995-02-15 |