The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sechrist Monoplace Hyperbaric Oxygen Chamber.
Device ID | K140559 |
510k Number | K140559 |
Device Name: | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER |
Classification | Chamber, Hyperbaric |
Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA AVE. Anaheim, CA 92807 |
Contact | Victor C Arellano |
Correspondent | Victor C Arellano SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA AVE. Anaheim, CA 92807 |
Product Code | CBF |
CFR Regulation Number | 868.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-05 |
Decision Date | 2014-05-30 |