510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885042Substantially Equivalent

Sony Trinitron Color Video Monitor Pvm-1343Md

Sony Medical Electronics Co., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885042 is the FDA 510(k) clearance record for SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD, a class I device, cleared for Sony Medical Electronics Co. on under FDA product code KQM (Camera, Surgical And Accessories). FDA records list 8 510(k) clearances for Sony Medical Electronics Co., from to . As of , FDA records show no recalls naming K885042.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KQM Camera, Surgical And Accessories
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sony Medical Electronics Co. 45 W. St., North Attleboro MA
Third party review
No

Clearances, product code KQM

Trailing 12 months

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

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