Model TM101 Temperature Monitor
by Fisher & Paykel Electronics, Ltd. 510(k)
Active
510(k) K902386
Overview
The Model TM101 Temperature Monitor is a medical device classified under the FDA’s product code FLL, intended for monitoring temperature in clinical settings. It is designed to provide accurate readings of physiological temperature, supporting patient care and diagnostic procedures in general hospital environments. The device operates as a standalone monitor, ensuring real-time temperature assessment for clinical decision-making.
This device is supplied as a reusable medical instrument, intended for use in regulated hospital settings. It has received FDA 510(k) clearance under the Traditional review pathway, with a decision date of January 28, 1992. The Model TM101 is not specified as MRI-safe or sterile upon supply, and no additional regulatory markings beyond its FDA clearance are indicated in the available data. Storage and maintenance requirements are not detailed in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902386 | Date28 Jan 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- FDA applicant
- Fisher & Paykel Electronics , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fisher & Paykel Electronics, Ltd.
Questions
What is the TM101 Temperature Monitor used for?
The TM101 Temperature Monitor is designed to measure physiological temperature in clinical settings, supporting patient care and diagnostic procedures. Its real-time readings help clinicians make informed decisions during general hospital care, such as monitoring fever, hypothermia, or postoperative temperature trends.
Is the TM101 Temperature Monitor reusable or single-use?
The TM101 Temperature Monitor is supplied as a reusable medical device. It is intended for repeated use in regulated hospital environments, provided it undergoes proper cleaning, disinfection, and maintenance between uses to ensure accuracy and safety.
Does the TM101 Temperature Monitor come sterile?
No, the TM101 Temperature Monitor is not supplied sterile. It is intended for reusable clinical use in hospital settings, where standard infection control protocols must be followed before each use to maintain hygiene and reliability.
What regulatory approval does the TM101 Temperature Monitor hold?
The TM101 Temperature Monitor has received FDA 510(k) clearance under the Traditional review pathway, with a decision date of January 28, 1992. This clearance confirms its substantial equivalence to a predicate device for monitoring temperature in general hospital environments.
Are there specific storage requirements for the TM101 Temperature Monitor?
The available specifications do not detail specific storage requirements for the TM101 Temperature Monitor. However, as a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and accuracy for repeated use.