Model 410T Telecommunication System
by GE Medical Systems Information Technologies
510(k) K895045
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895045 | Date6 Nov 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 23 Sep 2026
The Model 410t Telecommunication System is a System, Monitoring, Perinatal device. It is substantially equivalent and has a device class of 2. The device is used in the medical specialty of Obstetrics/Gynecology.
The device has an FDA 510K authorization and is supplied by Ge Medical Systems Information Technologies. It has a regulation number of 884.2740 and a product code of HGM. The device is used in the field of perinatal monitoring.
Other devices from GE Medical Systems Information Technologies, Inc.
See all devices from GE Medical Systems Information Technologies, Inc. →
Questions
AI-generated answers, 23 Sep 2026
What is the Model 410T Telecommunication System used for?
The Model 410T Telecommunication System is used in the field of perinatal monitoring, specifically in the medical specialty of Obstetrics/Gynecology.
What is the device class of the Model 410T Telecommunication System?
The device class of the Model 410T Telecommunication System is 2, and it has a regulation number of 884.2740.
What type of authorization does the Model 410T Telecommunication System have?
The Model 410T Telecommunication System has an FDA 510K authorization.