The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Ventilator Interface 9291/4.
| Device ID | K922314 |
| 510k Number | K922314 |
| Device Name: | VENTILATOR INTERFACE 9291/4 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Morten Nielson |
| Correspondent | Morten Nielson S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-18 |
| Decision Date | 1992-12-17 |