Odis Obstetrical Display Info System, HP M1370A
by Hewlett-Packard Co. 510(k)
Active
510(k) K892354
Overview
The ODIS Obstetrical Display Info System, HP M1370A, is a perinatal monitoring system. It is designed to display clinical information related to obstetrical care.
This device is manufactured by Hewlett-Packard Co. and has received FDA 510(k) clearance. It is classified as a Class II medical device under regulation number 884.2740.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892354 | Date8 Aug 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HGM
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2740
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hewlett-Packard Co.
Questions
What is the ODIS HP M1370A used for?
The ODIS HP M1370A is a perinatal monitoring system manufactured by Hewlett-Packard Co. It is specifically designed to display clinical information relevant to obstetrical care.
What is the regulatory status of the ODIS HP M1370A?
This device is classified as a Class II medical device under regulation number 884.2740. It has received FDA 510(k) clearance, which indicates that the system was found to be substantially equivalent to other legally marketed devices.
How was the ODIS HP M1370A cleared for use?
The system was submitted for review under the Obstetrics/Gynecology advisory committee. It is identified by the product code HGM and was cleared through the traditional 510(k) pathway.