FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYGEN CONCENTRATOR
K Number: K850346
·
Decision Feb 4, 1985
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
20
Review Days
7
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Basic Information
- Device Name
- OXYGEN CONCENTRATOR
- K Number
- K850346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Inspiron Corp.
- Date Received
- January 28, 1985
- Decision Date
- February 4, 1985
- Product Code
- CAW
- 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K860838 | INSPIRON DOUBLE SWIVEL TRACH ADAPTER | Apr 9, 1986 | Substantially Equivalent |
| K843932 | VAPOR-PHASE HUMIDIFIER SYS-ADVANCED | Oct 18, 1984 | Substantially Equivalent |
| K840935 | MANUAL RESUSCITATION SYSTEM | Apr 5, 1984 | Substantially Equivalent |
| K841158 | NEBULO 28 NEBULIZER KIT | Mar 30, 1984 | Substantially Equivalent |
| K840418 | INSPIRATORY/EXPIRATORY MUSCLE EXERCIS | Feb 17, 1984 | Substantially Equivalent |
| K834290 | INSPIRON LIQUID OXYGEN SYSTEM | Feb 4, 1984 | Substantially Equivalent |
| K772070 | VENTILATOR SETUP, VOLUME | Nov 15, 1977 | Substantially Equivalent |
| K772069 | VOL. VENTILATOR SETUP W/OUT NEBULIZER | Nov 15, 1977 | Substantially Equivalent |
| K772068 | MANIFOLD & NEBULIZER, UNIVERSAL | Nov 15, 1977 | Substantially Equivalent |
| K772072 | MANIFOLD & NEBU. FOR DOUB. LINE MACH. | Nov 15, 1977 | Substantially Equivalent |