510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162627Substantially Equivalent

EnsoSleep

Ensodata, Inc., Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162627 is the FDA 510(k) clearance record for EnsoSleep, a class II device, cleared for Ensodata, Inc. on under FDA product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph). FDA's definition for product code OLZ reads: "Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G...". FDA records list 3 510(k) clearances for Ensodata, Inc., from to . As of , FDA records show no recalls naming K162627.

Clearance record

Decision date
Received
(192 days to decision)
Product code
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Ensodata, Inc. 111 N. Fairchild St., Suite 240, Madison WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLZ

Trailing 12 months
4 clearances under product code OLZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260