FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPACELABS ARKON ANESTHESIA WORKSTATION
K Number: K113051
·
Decision Mar 22, 2012
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
498
Applicant Total
10
Review Days
161
Basic Information
- Device Name
- SPACELABS ARKON ANESTHESIA WORKSTATION
- K Number
- K113051
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPACELABS HEALTHCARE
- Date Received
- October 13, 2011
- Decision Date
- March 22, 2012
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by SPACELABS HEALTHCARE
| K Number | Device Name | ||
|---|---|---|---|
| K150329 | elance Vital Signs Monitor, Central Monitor Software | Nov 5, 2015 | Substantially Equivalent |
| K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER | Sep 9, 2014 | Substantially Equivalent |
| K122146 | XHIBIT CENTRAL STATION, MODEL 96102 | Apr 22, 2013 | Substantially Equivalent |
| K130112 | CAPNO MODULE, 92517 | Mar 21, 2013 | Substantially Equivalent |
| K121017 | CAPNOGRAPHY PAD (92516) | Jul 13, 2012 | Substantially Equivalent |
| K112729 | BLEASE700/900 SERIES VENTILATORS | Jun 11, 2012 | Substantially Equivalent |
| K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) | Jun 6, 2012 | Substantially Equivalent |
| K112173 | SPEACELABS MULTIGAS MODULE | Oct 5, 2011 | Substantially Equivalent |
| K110779 | SPACELABS SMART DISCLOSURE SYSTEM | Apr 19, 2011 | Substantially Equivalent |