FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
INTELLISAVE AX700 ANESTHESIA SYSTEM
K Number: K122063
·
Decision Aug 2, 2013
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
1
Review Days
385
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Basic Information
- Device Name
- INTELLISAVE AX700 ANESTHESIA SYSTEM
- K Number
- K122063
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Anesthesia Care
- Date Received
- July 13, 2012
- Decision Date
- August 2, 2013
- 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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