FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AS3700 ANESTHSIA DELIVERY SYSTEM
K Number: K102471
·
Decision Feb 11, 2011
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
3
Review Days
165
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Basic Information
- Device Name
- AS3700 ANESTHSIA DELIVERY SYSTEM
- K Number
- K102471
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mindray DS USA, Inc.
- Date Received
- August 30, 2010
- Decision Date
- February 11, 2011
- 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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