510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K991562Substantially Equivalent

Pascal Medical Ab Meniett 20

Pascal Medical AB, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991562 is the FDA 510(k) clearance record for PASCAL MEDICAL AB MENIETT 20, a class II device, cleared for Pascal Medical AB on under FDA product code ETY (Tester, Auditory Impedance). FDA records list one 510(k) clearance for Pascal Medical AB. As of , FDA records show no recalls naming K991562.

Clearance record

Decision date
Received
(238 days to decision)
Product code
ETY Tester, Auditory Impedance
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Pascal Medical AB 7307 Glouchester Dr., Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code ETY

Trailing 12 months

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

FDA records show no clearances under product code ETY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ETY, 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