The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Vital Signs Module.
| Device ID | K915697 |
| 510k Number | K915697 |
| Device Name: | CRITIKON VITAL SIGNS MODULE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Contact | Annette Hillring |
| Correspondent | Annette Hillring CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-23 |
| Decision Date | 1993-07-01 |