Sequal Technologies, Inc.
San Diego, CA, US
Sequal Technologies, Inc. appears in FDA device records in San Diego, CA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Sequal Technologies, Inc. between 2001 and 2010. The busiest year on record is 2009, with 2. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100920 | MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES | CAW | Substantially Equivalent | |
| K091541 | MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES | CAW | Substantially Equivalent | |
| K083163 | OMNI 2 OXYGEN SYSTEM | CAW | Substantially Equivalent | |
| K042262 | INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 | CAW | Substantially Equivalent | |
| K013931 | OMNI OXYGEN SYSTEM, MODEL 1000 | CAW | Substantially Equivalent | |
| K003472 | INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM | CAW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0567-2010 | SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen. | Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain