The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Cufflink Non-invasive Blood Pressure Analyzer.
| Device ID | K942546 |
| 510k Number | K942546 |
| Device Name: | CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DYNATECH/NEVADA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein DYNATECH/NEVADA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1995-01-27 |