FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORTABLE GASEOUS OXGYEN CONTAINER
K Number: K852663
·
Decision Aug 29, 1985
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- PORTABLE GASEOUS OXGYEN CONTAINER
- K Number
- K852663
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cryogenic Assoc.
- Date Received
- June 24, 1985
- Decision Date
- August 29, 1985
- Product Code
- CAN
- 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 |
|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | FDA class 1 | Anesthesiology |
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Other Clearances by Cryogenic Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K883590 | OXYTROL | Nov 2, 1988 | Substantially Equivalent |
| K841808 | STROLLER SPRINT | May 16, 1984 | Substantially Equivalent |
| K822789 | ROOMATE II | Oct 15, 1982 | Substantially Equivalent |
| K801104 | ROOMMATE-OXYGEN CONCENTRATOR | May 23, 1980 | Substantially Equivalent |
| K800742 | LIBERATOR/STROLLER II SYSTEM | May 23, 1980 | Substantially Equivalent |