The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Plus Vital Signs Monoitor.
Device ID | K943709 |
510k Number | K943709 |
Device Name: | DINAMAP PLUS VITAL SIGNS MONOITOR |
Classification | Electrocardiograph |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
Contact | Annette M Hillring |
Correspondent | Annette M Hillring CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-01 |
Decision Date | 1995-06-16 |