The following data is part of a premarket notification filed by Sechrist with the FDA for Sechrist Iv-100b Savi System.
| Device ID | K920121 |
| 510k Number | K920121 |
| Device Name: | SECHRIST IV-100B SAVI SYSTEM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | SECHRIST 4225 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Lee Adair |
| Correspondent | Lee Adair SECHRIST 4225 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-13 |
| Decision Date | 1993-02-01 |