FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAS MODULE II, MODEL 0998-00-0143
K Number: K974903
·
Decision Mar 13, 1998
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
16
Applicant Total
136
Review Days
72
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Basic Information
- Device Name
- GAS MODULE II, MODEL 0998-00-0143
- K Number
- K974903
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Datascope Corp.
- Date Received
- December 31, 1997
- Decision Date
- March 13, 1998
- Product Code
- CBS
- 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 |
|---|---|---|---|
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | FDA class 2 | Anesthesiology |
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