Physio-Dyne Easi - Lab
by Physio-Dyne
510(k) K922660
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922660 | Date8 Apr 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1730
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Physio-Dyne Easi - Lab is a computer-based oxygen-uptake device designed to facilitate the sampling of analog signals during medical procedures. It is particularly useful in tumor ablation, where precise monitoring and control of the procedure are crucial.
This device received FDA 510(k) clearance (K922660) on April 8, 1993, and is classified as a Class II device under regulation number 868.1730. It is supplied by Physio-Dyne and is intended for use in anesthesiology-related applications.
Questions
AI-generated answers, 19 Sep 2026
What medical specialties or procedures is the Physio-Dyne EASI-LAB primarily used for, and why is it considered important in those contexts?
The Physio-Dyne EASI-LAB is primarily used in anesthesiology-related applications, particularly during tumor ablation procedures. It is designed to sample and monitor analog signals in real-time, which helps clinicians maintain precise control and monitoring of critical physiological parameters during these delicate interventions. This ensures safer and more effective outcomes by providing immediate feedback on key metrics.
Is the Physio-Dyne EASI-LAB a single-use device, or can it be reused after sterilization? If so, what sterilization methods are recommended?
The provided specifications do not explicitly state whether the Physio-Dyne EASI-LAB is single-use or reusable. However, since it is a computer-based oxygen-uptake device intended for medical procedures, it is likely designed for single-use to ensure patient safety and data integrity. Reuse would require validation of sterilization methods (e.g., autoclave, ethylene oxide, or gamma irradiation), but no such details are provided in the data. Clinicians should follow manufacturer guidelines or institutional protocols if reuse is considered.
How is the Physio-Dyne EASI-LAB supplied, and what should buyers expect in terms of packaging and components?
The Physio-Dyne EASI-LAB is supplied by Physio-Dyne as a computer-based system for oxygen-uptake monitoring. While exact packaging details are not specified, buyers can expect it to include the core device, necessary analog signal sampling hardware, and likely software for data acquisition and analysis. Since it is classified under product code BZL (a category for diagnostic and monitoring devices), it may also require calibration tools or accessories for proper setup. Buyers should confirm with Physio-Dyne for precise contents and compatibility with existing hospital systems.
What regulatory pathway was followed for FDA clearance of the Physio-Dyne EASI-LAB, and what does this mean for clinicians or facilities using it?
The Physio-Dyne EASI-LAB received FDA 510(k) clearance (K922660) under the Traditional 510(k) pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance was granted on April 8, 1993, and it is classified as a Class II device under regulation 868.1730. For clinicians, this indicates that the device has undergone FDA review for safety and effectiveness, though ongoing compliance with post-market surveillance requirements applies. Facilities should ensure proper training and adherence to manufacturer instructions for optimal use.