Trudell Medical Intl.
London, CA
Trudell Medical Intl. appears in FDA device records in London, CA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Trudell Medical Intl. between 1999 and 2014. The busiest year on record is 2013, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140919 | RESPICONNECT ADAPTER | CAF | Substantially Equivalent | |
| K131881 | OMBRA TABLE TOP COMPRESSOR | BTI | Substantially Equivalent | |
| K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | BWF | Substantially Equivalent | |
| K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | CAF | Substantially Equivalent | |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | NVP | Substantially Equivalent | |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | |
| K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | CAF | Substantially Equivalent | |
| K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | CAF | Substantially Equivalent | |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR | NVP | Substantially Equivalent | |
| K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER | CAF | Substantially Equivalent | |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | |
| K032972 | AEROCHAMBER MAX VALVED HOLDING CHAMBER | CAF | Substantially Equivalent | |
| K012368 | AEROPEP | BWF | Substantially Equivalent | |
| K001137 | AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) | CAF | Substantially Equivalent | |
| K992917 | AEROCHAMBER PLUS VALVED HOLDING CHAMBER | CAF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain