FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIRONICS GOLOX
K Number: K072723
·
Decision Mar 20, 2008
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
54
Applicant Total
172
Review Days
176
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Basic Information
- Device Name
- RESPIRONICS GOLOX
- K Number
- K072723
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5655
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- September 26, 2007
- Decision Date
- March 20, 2008
- Product Code
- BYJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
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
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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
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