FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
K Number: K970456
·
Decision Oct 3, 1997
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
16
Review Days
239
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Basic Information
- Device Name
- HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
- K Number
- K970456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hewlett-Packard GmbH
- Date Received
- February 6, 1997
- Decision Date
- October 3, 1997
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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