The following data is part of a premarket notification filed by Critkon, Inc. with the FDA for Model P-81 Critikon Printer.
| Device ID | K915468 |
| 510k Number | K915468 |
| Device Name: | MODEL P-81 CRITIKON PRINTER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CRITKON, INC. 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 |
| Contact | John Matson |
| Correspondent | John Matson CRITKON, INC. 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-09-22 |