The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Capnomac Ii(tm) Anesthesia Multigas Monitor.
| Device ID | K891076 |
| 510k Number | K891076 |
| Device Name: | CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 127 UPHAM ST. Melrose, MA 02176 |
| Contact | Jouko Vallikari |
| Correspondent | Jouko Vallikari DATEX DIVISION INSTRUMENTARIUM CORP. 127 UPHAM ST. Melrose, MA 02176 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1989-08-02 |