The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Vitalnet(tm) System (dinamap(tm), Model 2200).
Device ID | K871418 |
510k Number | K871418 |
Device Name: | VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Contact | Melanie Sabo |
Correspondent | Melanie Sabo CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-08 |
Decision Date | 1987-07-29 |