Cor-Temp-Temp Monitor
by Product Research Organizations, Inc.
510(k) K840675
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840675 | Date17 Apr 1984 | 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- Withdrawn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
- Product Research Organizations,Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cor-Temp-Temp Monitor is a medical device classified under product code FLL, intended for monitoring core body temperature. It is designed to provide accurate temperature readings, likely within a clinical or hospital setting, to assist in patient care and monitoring vital signs. This device falls under the broader category of temperature monitoring instruments, ensuring precise measurements for diagnostic or therapeutic purposes.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K840675), with a traditional review process through the General Hospital Advisory Committee. It was authorized in 1984 and is intended for use in hospital environments. No specific sterility or MRI safety information is provided in the available data, and its storage conditions are not detailed beyond standard medical device handling. The device’s specifications do not indicate single-use or reusable status beyond the regulatory submission context.
Questions
AI-generated answers, 1 Oct 2026
What is the Cor-Temp-Temp Monitor used for?
The Cor-Temp-Temp Monitor is designed specifically for monitoring core body temperature in clinical or hospital environments. It provides accurate temperature readings to assist healthcare providers in tracking vital signs, which is critical for diagnosing conditions, guiding therapeutic interventions, and ensuring patient stability during procedures or recovery.
Is the Cor-Temp-Temp Monitor a single-use or reusable device?
The Cor-Temp-Temp Monitor is classified as a reusable medical instrument. This designation is based on its regulatory submission under the FDA 510(k) pathway, where the device’s intended reuse was part of the approval process. Reusable devices require proper cleaning, disinfection, and maintenance between uses to ensure safety and functionality.
What regulatory approval does the Cor-Temp-Temp Monitor hold?
The Cor-Temp-Temp Monitor holds FDA 510(k) clearance under the reference number K840675. This clearance was granted through a traditional review process, with input from the General Hospital Advisory Committee, and was authorized in 1984. The device is intended for use in hospital settings and falls under product code FLL.
Are there any specific storage requirements for the Cor-Temp-Temp Monitor?
The available data does not provide detailed storage conditions for the Cor-Temp-Temp Monitor beyond standard medical device handling practices. Generally, reusable medical devices should be stored in a clean, dry environment, protected from physical damage and contamination, and according to manufacturer guidelines if additional specifications are provided.
Does the Cor-Temp-Temp Monitor have any special considerations for sterility or MRI safety?
The provided information does not specify whether the Cor-Temp-Temp Monitor is sterile or intended for use in MRI environments. If sterility is required for a particular use case, it would typically be achieved through sterilization processes like autoclaving or chemical sterilization before patient contact. For MRI safety, additional documentation or manufacturer specifications would be needed to confirm compatibility.