FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
K Number: K071397
·
Decision Oct 1, 2007
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
14
Review Days
133
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Basic Information
- Device Name
- DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
- K Number
- K071397
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sunrise Medical
- Date Received
- May 21, 2007
- Decision Date
- October 1, 2007
- 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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