Emano Metrics, Inc.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- UroflowmeterProduct code EXY (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1800
Recalls & enforcement
- Class IIOngoing2026-05-29Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was theref…
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Emano Metrics, Inc. (FEI 3021350028) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021350028-emano-metrics-inc/
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