The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Adult/ped./neonatal Vital Signs.
| Device ID | K813527 |
| 510k Number | K813527 |
| Device Name: | DINAMAP ADULT/PED./NEONATAL VITAL SIGNS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-16 |
| Decision Date | 1982-01-12 |