Bi-Temp Temperature Monitor, Model TM-300D
by Respiratory Support Products, Inc.
510(k) K913082
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913082 | Date11 Dec 1991 | 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- Withdrawn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
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Bi-Temp Temperature Monitor, Model TM-300D, is a dual-channel temperature monitoring device designed for clinical use in general hospital settings. It measures and displays temperature readings from two separate sensors, enabling precise monitoring of patient physiological temperatures during medical procedures or patient care.
This device is intended for single-use or reusable applications in regulated hospital environments, adhering to FDA 510(k) clearance (K913082). Supplied as a reusable medical instrument, it requires proper sterilization and maintenance per manufacturer guidelines. No specific MRI safety information is provided, and its use is governed by the traditional 510(k) review pathway under the General Hospital product code (FLL)