FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERVO GAS MONITOR 120
K Number: K861625
·
Decision May 2, 1986
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
63
Review Days
3
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
- SERVO GAS MONITOR 120
- K Number
- K861625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Elema AB
- Date Received
- April 29, 1986
- Decision Date
- May 2, 1986
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCL), ordered by most recent decision date.
OxyMinder Pro (10310)
FDA 510(k)
FDA Class 2
·Anesthesiology
Smart Check O2 (MA0236)
FDA 510(k)
FDA Class 2
·Anesthesiology
Maxtec MaxO2 ME+p
FDA 510(k)
FDA Class 2
·Anesthesiology
Percent Oxygen Sensors
FDA 510(k)
FDA Class 2
·Anesthesiology
OxyMinder
FDA 510(k)
FDA Class 2
·Anesthesiology
Accu O2 Oxygen Analyzer
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Siemens Elema AB
| K Number | Device Name | ||
|---|---|---|---|
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Sep 5, 2003 | Substantially Equivalent |
| K010923 | KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E | Jan 23, 2002 | Substantially Equivalent |
| K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E | Dec 18, 2001 | Substantially Equivalent |
| K002137 | CATHCOR DESKTOP | Oct 5, 2000 | Substantially Equivalent |
| K001315 | MODIFICATION TO KION ANESTHESIA SYSTEM | May 26, 2000 | Substantially Equivalent |
| K970839 | SERVO VENTILATOR 300A | Oct 14, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K960010 | SERVO VENTILATOR 300 COMPUTER INTERFACE | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960168 | SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K872278 | SIEMENS O2-AIR MIXER 965 | Sep 3, 1987 | Substantially Equivalent |
| K871354 | SERVO VENTILATOR 900 C/D | Jul 21, 1987 | Substantially Equivalent |