FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
METANEB
K Number: K124032
·
Decision Apr 25, 2013
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
24
Applicant Total
5
Review Days
118
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Basic Information
- Device Name
- METANEB
- K Number
- K124032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom Services Pte, Ltd.
- Date Received
- December 28, 2012
- Decision Date
- April 25, 2013
- Product Code
- NHJ
- 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 |
|---|---|---|---|
| NHJ | Device, Positive Pressure Breathing, Intermittent | FDA class 2 | Anesthesiology |
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