The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Cardiocap(tm) Pulse Oximetry Module Cos-104.
| Device ID | K873859 |
| 510k Number | K873859 |
| Device Name: | CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104 |
| Classification | Oximeter |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
| Contact | Hannu Ahjopalo |
| Correspondent | Hannu Ahjopalo DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-22 |
| Decision Date | 1987-12-29 |