510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902954Substantially Equivalent

Ober2 Monitor, Eye Movement (Ophthalmic)

Permobil, AB, Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902954 is the FDA 510(k) clearance record for OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC), a class II device, cleared for Permobil AB on under FDA product code HFC (Aspirator, Endocervical). FDA records list 18 510(k) clearances for Permobil AB, from to . As of , FDA records show no recalls naming K902954.

Clearance record

Decision date
Received
(49 days to decision)
Product code
HFC Aspirator, Endocervical
Regulation
21 CFR 884.1050
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Permobil AB 30 Ray Ave., Burlington MA
Third party review
No

Clearances, product code HFC

Trailing 12 months

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

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