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510(k) Data Aggregation
(187 days)
IMMERSION HYDROBATH
To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue
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This document is a 510(k) clearance letter from the FDA for an "Immersion hydrobath." It signifies that the device is substantially equivalent to a legally marketed predicate device. However, this type of regulatory document does not typically contain the detailed information required to describe acceptance criteria and a study proving device performance as requested.
The letter focuses on regulatory approval, referencing existing regulations and indicating that the device can be marketed. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information).
Therefore, based solely on the provided text, I cannot extract the information required to answer your prompt. This document is a regulatory approval, not a performance study report.
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