FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYGEN MONITOR/CONTROLLER
K Number: K833496
·
Decision Dec 16, 1983
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
5
Review Days
70
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
- OXYGEN MONITOR/CONTROLLER
- K Number
- K833496
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Oxequip Health Ind.
- Date Received
- October 7, 1983
- Decision Date
- December 16, 1983
- 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 Oxequip Health Ind.
| K Number | Device Name | ||
|---|---|---|---|
| K812624 | OXEQUIP CONDUCTIVE & NON ANES. BREATH | Oct 26, 1981 | Substantially Equivalent |
| K811987 | OXY-QUIK MARK IV OXYGEN INHALATOR | Jul 27, 1981 | Substantially Equivalent |
| K800369 | TRI PAC MOUTH PROP | Feb 28, 1980 | Substantially Equivalent |
| K792356 | OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR | Dec 4, 1979 | Substantially Equivalent |