The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Oxytrak(tm) Pulse Oximeter.
Device ID | K894100 |
510k Number | K894100 |
Device Name: | OXYTRAK(TM) PULSE OXIMETER |
Classification | Oximeter |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
Contact | Raymond E Ursick |
Correspondent | Raymond E Ursick CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-09 |
Decision Date | 1990-05-09 |