The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for The Infant Flow System.
Device ID | K930713 |
510k Number | K930713 |
Device Name: | THE INFANT FLOW SYSTEM |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Contact | Lee Adair |
Correspondent | Lee Adair SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-11 |
Decision Date | 1993-09-16 |