FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOUNTED MEDICAL OXYGEN SYSTEM
K Number: K113767
·
Decision Jun 29, 2012
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
54
Applicant Total
4
Review Days
191
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Basic Information
- Device Name
- MOUNTED MEDICAL OXYGEN SYSTEM
- K Number
- K113767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5655
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Essex Industries, Inc.
- Date Received
- December 21, 2011
- Decision Date
- June 29, 2012
- Product Code
- BYJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Expedited Review
- Y
- 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 |
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