510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071028Substantially Equivalent

Viewmate System

Abbott Medical, West Berlin NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071028 is the FDA 510(k) clearance record for VIEWMATE SYSTEM, a class I device, cleared for Ep Medsystems on under FDA product code ITN (Splint, Denis Brown). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K071028.

Clearance record

Decision date
Received
(20 days to decision)
Product code
ITN Splint, Denis Brown
Regulation
21 CFR 890.3675
Device class
Class I
Review panel
Physical Medicine
Applicant
Ep Medsystems Cooper Run Executive Park, West Berlin NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ITN

Trailing 12 months

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

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