FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIBERATOR/STROLLER
K Number: K760787
·
Decision Oct 22, 1976
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
54
Applicant Total
10
Review Days
16
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Basic Information
- Device Name
- LIBERATOR/STROLLER
- K Number
- K760787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5655
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Burditt & Calkins-Siemens-Elema
- Date Received
- October 6, 1976
- Decision Date
- October 22, 1976
- 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
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FDA Class 2
·Anesthesiology
PRECISION LIQUID OXYGEN SYSTEM
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FDA Class 2
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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 Burditt & Calkins-Siemens-Elema
| K Number | Device Name | ||
|---|---|---|---|
| K833519 | PULSE GENERATOR MODEL 688 | Jan 30, 1984 | Substantially Equivalent |
| K833155 | RAYDEN MEDICAL MINI PULSE VOLUME RECORD | Jan 26, 1984 | Substantially Equivalent |
| K830344 | SIEMENS-ELMA PULSE GENERATOR #718 | May 27, 1983 | Substantially Equivalent |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | Dec 30, 1982 | Substantially Equivalent |
| K823591 | AMEDA HAND BREAST PUMP | Dec 28, 1982 | Substantially Equivalent |
| K822239 | COAXIAL BIPOLAR PACING ELECTRODE | Oct 4, 1982 | Substantially Equivalent |
| K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 | Jul 26, 1982 | Substantially Equivalent |
| K803111 | ERECTAID | Jan 23, 1981 | Substantially Equivalent |
| K802607 | TERPERATUR SENSING DEVICE | Nov 19, 1980 | Substantially Equivalent |