The following data is part of a premarket notification filed by Icor Ab with the FDA for Et Tube Placement Detector (with Colibri Indicator).
| Device ID | K952325 |
| 510k Number | K952325 |
| Device Name: | ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Contact | Andras Gedeon |
| Correspondent | Andras Gedeon ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1995-07-31 |