The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type Expired Co2 9270, Capnograph.
| Device ID | K895001 |
| 510k Number | K895001 |
| Device Name: | TYPE EXPIRED CO2 9270, CAPNOGRAPH |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Lisbeth Isbrandt |
| Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-03 |
| Decision Date | 1990-02-22 |