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 |