FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
K Number: K131883
·
Decision Apr 11, 2014
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
14
Review Days
290
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Basic Information
- Device Name
- AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
- K Number
- K131883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inovise Medical, Inc.
- Date Received
- June 25, 2013
- Decision Date
- April 11, 2014
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Inovise Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Mar 18, 2016 | Substantially Equivalent |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Oct 11, 2013 | Substantially Equivalent |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | Sep 20, 2012 | Substantially Equivalent |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Oct 24, 2011 | Substantially Equivalent |
| K103516 | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 | Feb 4, 2011 | Substantially Equivalent |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Sep 25, 2008 | Substantially Equivalent |
| K073545 | AUDICOR, HEMO AMBULATORY MONITOR | Sep 9, 2008 | Substantially Equivalent |
| K070136 | AUDICOR 200 SYSTEM, MODELS 200D AND 200S | Apr 13, 2007 | Substantially Equivalent |
| K051450 | EXTENDED MEASUREMENTS SYSTEM | Nov 10, 2005 | Substantially Equivalent |
| K043074 | LIBERTY SYSTEM | Feb 22, 2005 | Substantially Equivalent |