The following data is part of a premarket notification filed by Fraser Harlake, Inc. with the FDA for Sphygomano Meter.
| Device ID | K833799 |
| 510k Number | K833799 |
| Device Name: | SPHYGOMANO METER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FRASER HARLAKE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-01 |
| Decision Date | 1984-05-14 |