The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Vital Signs Monitor Models 9300 And 9320/9340.
Device ID | K942700 |
510k Number | K942700 |
Device Name: | DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
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 | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-08 |
Decision Date | 1995-03-01 |