FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROOMMATE-OXYGEN CONCENTRATOR
K Number: K801104
·
Decision May 23, 1980
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
6
Review Days
14
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Basic Information
- Device Name
- ROOMMATE-OXYGEN CONCENTRATOR
- K Number
- K801104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cryogenic Assoc.
- Date Received
- May 9, 1980
- Decision Date
- May 23, 1980
- 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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Other Clearances by Cryogenic Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K883590 | OXYTROL | Nov 2, 1988 | Substantially Equivalent |
| K852663 | PORTABLE GASEOUS OXGYEN CONTAINER | Aug 29, 1985 | Substantially Equivalent |
| K841808 | STROLLER SPRINT | May 16, 1984 | Substantially Equivalent |
| K822789 | ROOMATE II | Oct 15, 1982 | Substantially Equivalent |
| K800742 | LIBERATOR/STROLLER II SYSTEM | May 23, 1980 | Substantially Equivalent |