Hewlett Apckard Series 50 Ob Tracevue Obstetrical Surveillance and Archiving System
FDA 510(k) K970456 · Hewlett-Packard GmbH
510(k) numberK970456
Submission
- Device name
- Hewlett Apckard Series 50 Ob Tracevue Obstetrical Surveillance and Archiving System
- Applicant
- Hewlett-Packard GmbH
Wuerttemberg, DE - Received
- February 6, 1997
- Decision date
- October 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGM – System, Monitoring, Perinatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2740
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Hewlett Apckard Series 50 Ob Tracevue Obstetrical Surveillance and Archiving System cleared by the FDA?
Hewlett Apckard Series 50 Ob Tracevue Obstetrical Surveillance and Archiving System (K970456) received a 510(k) decision of Substantially Equivalent on October 3, 1997, 239 days after the submission was received.
What is the product code of K970456?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.