HS17/HS18 Series Monitors
510(k) K820670
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820670 | Date9 Apr 1982 | 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- Withdrawn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
- FLL
- FDA applicant
- Medtel Pty. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Hs17/Hs18 Series Monitors are electronic clinical thermometers. They are classified as a device class 2 and are used in the medical specialty of General Hospital.
The Hs17/Hs18 Series Monitors are supplied with a product code of FLL and are regulated under the number 880.2910. They have been found to be substantially equivalent and have an FDA 510K authorization with the k number K820670. The device was decided to be substantially equivalent on April 9, 1982.
Other devices from Medtel Pty., Ltd.
Questions
AI-generated answers, 22 Sep 2026
What is the HS17/HS18 Series Monitors used for?
The HS17/HS18 Series Monitors are used in the medical specialty of General Hospital as electronic clinical thermometers.
What is the regulatory status of the HS17/HS18 Series Monitors?
The device has been found to be substantially equivalent and has an FDA 510K authorization with the k number K820670.
How are the HS17/HS18 Series Monitors supplied?
The HS17/HS18 Series Monitors are supplied with a product code of FLL and are regulated under the number 880.2910.