The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Mps Select Portable Monitor.
Device ID | K982342 |
510k Number | K982342 |
Device Name: | DINAMAP MPS SELECT PORTABLE MONITOR |
Classification | System, Network And Communication, Physiological Monitors |
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 | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-06 |
Decision Date | 1998-08-14 |
Summary: | summary |