FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED
K Number: K914295
·
Decision Apr 10, 1992
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
21
Applicant Total
4
Review Days
214
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Basic Information
- Device Name
- ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED
- K Number
- K914295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bruel & Kjaer
- Date Received
- September 9, 1991
- Decision Date
- April 10, 1992
- Product Code
- CBQ
- 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 |
|---|---|---|---|
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | FDA class 2 | Anesthesiology |
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