The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Model 3300e/er Monoplace Hyperbaric Oxygen Chamber.
| Device ID | K052713 |
| 510k Number | K052713 |
| Device Name: | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Greg Godfrey |
| Correspondent | Greg Godfrey 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 | 2005-09-29 |
| Decision Date | 2005-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852682007934 | K052713 | 000 |
| 00899660002468 | K052713 | 000 |