The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Model 3200p/3200pr Hyperbaric Chamber.
Device ID | K950386 |
510k Number | K950386 |
Device Name: | MODEL 3200P/3200PR 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 | 1995-02-01 |
Decision Date | 1995-06-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00085268200710 | K950386 | 000 |
00085268200709 | K950386 | 000 |
00852682007453 | K950386 | 000 |
00852682007118 | K950386 | 000 |
00852682007101 | K950386 | 000 |
00852682007095 | K950386 | 000 |