MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
FDA 510(k) clearance K052713 · decided 2005-10-28
Clearance details
- K-number
- K052713
- Device name
- MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
- Applicant
- Sechrist Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-29
- Decision date
- 2005-10-28
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sechrist Industries
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hy recall (Z-0208-2013) | Sechrist Industries Inc | 2012-11-06 |
| Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hy recall (Z-0209-2013) | Sechrist Industries Inc | 2012-11-06 |