The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Model 2500e/2500er Hyperbaric Chamber.
Device ID | K934164 |
510k Number | K934164 |
Device Name: | MODEL 2500E/2500ER HYPERBARIC CHAMBER |
Classification | Chamber, Hyperbaric |
Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Contact | Kaoru Lee Adair |
Correspondent | Kaoru Lee Adair SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Product Code | CBF |
CFR Regulation Number | 868.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-27 |
Decision Date | 1995-06-13 |