The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Multicap Multigas Capnometer Pb252.
| Device ID | K853396 |
| 510k Number | K853396 |
| Device Name: | MULTICAP MULTIGAS CAPNOMETER PB252 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Contact | Olli Riikkala |
| Correspondent | Olli Riikkala INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-08-16 |