The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Millennium Infant Ventilator.
Device ID | K993167 |
510k Number | K993167 |
Device Name: | MILLENNIUM INFANT VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Contact | Greg Godfrey |
Correspondent | Greg Godfrey SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-22 |
Decision Date | 1999-11-10 |
Summary: | summary |