510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960044Substantially Equivalent

Ultramax/model Number A1

Entlab Oy, Richmond, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960044 is the FDA 510(k) clearance record for ULTRAMAX/MODEL NUMBER A1, a class II device, cleared for Entlab OY on under FDA product code LWI (Ultrasound, Sinus). FDA records list one 510(k) clearance for Entlab OY. As of , FDA records show no recalls naming K960044.

Clearance record

Decision date
Received
(213 days to decision)
Product code
LWI Ultrasound, Sinus
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Entlab OY 5671 Sandiford Pl., Richmond, CA
510(k) summary
Summary
Third party review
No

Clearances, product code LWI

Trailing 12 months

FDA records hold no clearances under product code LWI in the trailing twelve months.

FDA records show no clearances under product code LWI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260