FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MASTERSCREEN BODY
K Number: K936108
·
Decision Feb 3, 1995
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
10
Applicant Total
4
Review Days
403
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Basic Information
- Device Name
- MASTERSCREEN BODY
- K Number
- K936108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1760
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Erich Jaeger GmbH & Co. KG
- Date Received
- December 27, 1993
- Decision Date
- February 3, 1995
- Product Code
- JEH
- 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 |
|---|---|---|---|
| JEH | Plethysmograph, Volume | FDA class 2 | Anesthesiology |
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