FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIEMENS O2-AIR MIXER 965
K Number: K872278
·
Decision Sep 3, 1987
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
63
Review Days
80
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
- SIEMENS O2-AIR MIXER 965
- K Number
- K872278
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Elema AB
- Date Received
- June 15, 1987
- Decision Date
- September 3, 1987
- Product Code
- BZR
- 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 |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZR), ordered by most recent decision date.
F&P Optiflow Air/Oxygen Flow Source
FDA 510(k)
FDA Class 2
·Anesthesiology
Midas Flowmeter; eAVS
FDA 510(k)
FDA Class 2
·Anesthesiology
Maxtec MaxBlend2+p
FDA 510(k)
FDA Class 2
·Anesthesiology
FlowStar Analog Mixer Flowmeter
FDA 510(k)
FDA Class 2
·Anesthesiology
FlowStar Touch Digital Mixer Flowmeter
FDA 510(k)
FDA Class 2
·Anesthesiology
Quality Mix Blender, Oxymixer
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. |
| K871354 | SERVO VENTILATOR 900 C/D | Jul 21, 1987 | Substantially Equivalent |
| K871829 | SIEMENS DRY AIR COMPRESSOR | Jun 15, 1987 | Substantially Equivalent |