FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIBERATOR/STROLLER II SYSTEM
K Number: K800742
·
Decision May 23, 1980
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
54
Applicant Total
6
Review Days
50
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Basic Information
- Device Name
- LIBERATOR/STROLLER II SYSTEM
- K Number
- K800742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5655
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cryogenic Assoc.
- Date Received
- April 3, 1980
- Decision Date
- May 23, 1980
- Product Code
- BYJ
- 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 |
|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYJ), ordered by most recent decision date.
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
FDA 510(k)
FDA Class 2
·Anesthesiology
MOUNTED MEDICAL OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECISION LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
FDA 510(k)
FDA Class 2
·Anesthesiology
GOLOX-93
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO: SPIRIT
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K801104 | ROOMMATE-OXYGEN CONCENTRATOR | May 23, 1980 | Substantially Equivalent |