The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Vital Signs Monitor/pulse Oximeter.
Device ID | K874442 |
510k Number | K874442 |
Device Name: | DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER |
Classification | Oximeter |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Contact | Raymond E Ursick |
Correspondent | Raymond E Ursick CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-28 |
Decision Date | 1988-02-18 |