FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
OMBRA TABLE TOP COMPRESSOR
K Number: K131881
·
Decision Oct 24, 2013
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
12
Review Days
121
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OMBRA TABLE TOP COMPRESSOR
- K Number
- K131881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trudell Medical Intl.
- Date Received
- June 25, 2013
- Decision Date
- October 24, 2013
- Product Code
- BTI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTI), ordered by most recent decision date.
MEDICAL AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DK50 DS
FDA 510(k)
FDA Class 2
·Anesthesiology
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDICAL COMPRESSOR, MODELS DK50 D AND DM
FDA 510(k)
FDA Class 2
·Anesthesiology
MINIMATE COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTILAIR II MEDICAL AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Trudell Medical Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | May 16, 2013 | Substantially Equivalent |
| K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | Mar 11, 2013 | Substantially Equivalent |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | Jul 11, 2012 | Substantially Equivalent |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | Apr 18, 2011 | Substantially Equivalent |
| K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | Apr 9, 2009 | Substantially Equivalent |
| K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | Aug 12, 2008 | Substantially Equivalent |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR | Apr 11, 2007 | Substantially Equivalent |
| K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER | Feb 27, 2006 | Substantially Equivalent |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | Sep 21, 2005 | Substantially Equivalent |
| K032972 | AEROCHAMBER MAX VALVED HOLDING CHAMBER | Jan 14, 2004 | Substantially Equivalent |