Zephyr Technology Corporation is one of 18972 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Zephyr Technology Corporation - FDA 510(k) Cleared Devices
Recent clearances: PHYSIOLOGICAL DATA PROCESSOR, BIOMODULE 3-M1, BIOHARNESS
4
Total
4
Cleared
0
Denied
Zephyr Technology Corporation, specializes in performance monitoring technology for physiological and biomechanical data collection. The company, with a manufacturing facility in Annapolis, US, developed systems used across sports, defense, first responders, and academic research applications.
The company received 4 FDA 510(k) clearances from 4 total submissions, with all submissions focused on Cardiovascular devices. Clearances span from 2010 to 2013. Notable cleared devices include the PHYSIOLOGICAL DATA PROCESSOR, BIOMODULE 3-M1, and BIOHARNESS systems.
Zephyr's technology platform emphasizes estimated core body temperature monitoring and real-time physiological tracking. The system has been deployed in military training programs and collegiate athletics for heat stress prevention and performance optimization.
This company represents a historical regulatory record with no FDA 510(k) clearances in more than five years. Explore the device names, product codes, and clearance dates in the database for complete submission details.
FDA 510(k) Regulatory Record - Zephyr Technology Corporation
4 devices