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 | K100268 |
| 510k Number | K100268 |
| Device Name: | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Victor Arellano |
| Correspondent | Victor 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 | 2010-01-29 |
| Decision Date | 2010-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852682007842 | K100268 | 000 |
| 00852682007224 | K100268 | 000 |
| 00852682007996 | K100268 | 000 |
| 00899660002444 | K100268 | 000 |
| 00899660002437 | K100268 | 000 |
| 00899660002420 | K100268 | 000 |
| 00899660002413 | K100268 | 000 |
| 00899660002390 | K100268 | 000 |
| 00899660002185 | K100268 | 000 |
| 00899660002178 | K100268 | 000 |
| 00899660002161 | K100268 | 000 |
| 00852682007231 | K100268 | 000 |
| 00852682007248 | K100268 | 000 |
| 00852682007774 | K100268 | 000 |
| 00852682007767 | K100268 | 000 |
| 00852682007750 | K100268 | 000 |
| 00852682007743 | K100268 | 000 |
| 00852682007620 | K100268 | 000 |
| 00852682007613 | K100268 | 000 |
| 00852682007576 | K100268 | 000 |
| 00852682007569 | K100268 | 000 |
| 00852682007552 | K100268 | 000 |
| 00852682007255 | K100268 | 000 |
| 00899660002154 | K100268 | 000 |