The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Cardiocap Ii Tm Ch-resp Monitors.
| Device ID | K904355 |
| 510k Number | K904355 |
| Device Name: | CARDIOCAP II TM CH-RESP MONITORS |
| Classification | Electrocardiograph |
| Applicant | INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Contact | Hannu Ahjopalo |
| Correspondent | Hannu Ahjopalo INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1991-05-23 |