Keller Vital Signs Monitor, Kms 890+
by Keller Medical Specialties Products, Inc.
510(k) K990648
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990648 | Date10 Aug 1999 | 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- Withdrawn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
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Keller Vital Signs Monitor, Kms 890+, is a device that monitors arterial oxygen saturation, pulse rate, and measures blood pressure parameters. It is a combined pulse oximeter and non-invasive blood pressure monitor. The device is used to monitor vital signs. It is classified under the product code DXN. The device type is related to cardiovascular applications.
The Keller Vital Signs Monitor, Kms 890+, is supplied by Keller Medical Specialties Products, Inc. It has been found to be substantially equivalent to other devices on the market. The device has an FDA 510K authorization, with the decision code SESE. The device is associated with the k number K990648.
Other devices from Keller Medical Specialties Products, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the Keller Vital Signs Monitor KMS 890+ used for?
The Keller Vital Signs Monitor KMS 890+ is used to monitor vital signs, including arterial oxygen saturation, pulse rate, and blood pressure parameters, in cardiovascular applications.
Is the Keller Vital Signs Monitor KMS 890+ supplied sterile?
The device data does not specify if the Keller Vital Signs Monitor KMS 890+ is supplied sterile, but it is a non-invasive device.
What is the regulatory status of the Keller Vital Signs Monitor KMS 890+?
The Keller Vital Signs Monitor KMS 890+ has an FDA 510K authorization, with the decision code SESE, indicating it is substantially equivalent to other devices on the market.