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 |