FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATASCOPE MULTINEX II
K Number: K926451
·
Decision Aug 25, 1993
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
21
Applicant Total
136
Review Days
244
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Basic Information
- Device Name
- DATASCOPE MULTINEX II
- K Number
- K926451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Datascope Corp.
- Date Received
- December 24, 1992
- Decision Date
- August 25, 1993
- 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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