FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MADM
K Number: K140264
·
Decision Jan 5, 2015
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
5
Review Days
336
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Basic Information
- Device Name
- MADM
- K Number
- K140264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thornhill Research, Inc.
- Date Received
- February 3, 2014
- Decision Date
- January 5, 2015
- Product Code
- BSZ
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | Anesthesiology |
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