FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ApneaLink Air
K Number: K143272
·
Decision Apr 30, 2015
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
8
Review Days
167
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Basic Information
- Device Name
- ApneaLink Air
- K Number
- K143272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resmed Germany, Inc.
- Date Received
- November 14, 2014
- Decision Date
- April 30, 2015
- 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 Resmed Germany, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131932 | APNEALINK PRO | Nov 8, 2013 | Substantially Equivalent |
| K122715 | STELLAR 150 | Jun 17, 2013 | Substantially Equivalent |
| K113640 | STELLAR 150 | Apr 5, 2012 | Substantially Equivalent |
| K103167 | STELLAR 150 | Mar 1, 2011 | Substantially Equivalent |
| K083575 | APNEALINK PLUS, MODEL: 22328 | Mar 19, 2009 | Substantially Equivalent |
| K070263 | APNEALINK | Jun 15, 2007 | Substantially Equivalent |
| K061405 | APNEALINK, MODEL 22302 | Jul 25, 2006 | Substantially Equivalent |