MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER— 510(k) K052713
Substantially EquivalentSechrist Industries, Inc.
FDA 510(k) clearance K052713 for MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER, Substantially Equivalent on 2005-10-28. Applicant: Sechrist Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Sechrist Industries, Inc.
- Product code
- Code CBF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5470
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Anaheim, CA, US
Recent devices under product code CBF
view allMore clearances from Sechrist Industries, Inc.
view allAdverse events under product code CBF
product code CBF- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K052713
K-number listed on FDA's recall record- Z-0208-2013 — Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
- Z-0209-2013 — Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052713.
Data sourced from openFDA. This site is unofficial and independent of the FDA.