510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943613Substantially Equivalent

Nil

Sing Wah International Enterprises, Ltd., Connaught, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943613 is the FDA 510(k) clearance record for NIL, a class I device, cleared for Sing Wah International Enterprises , Ltd. on under FDA product code HOI (Spectacle, Magnifying). FDA records list 2 510(k) clearances for Sing Wah International Enterprises , Ltd., from to . As of , FDA records show no recalls naming K943613.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HOI Spectacle, Magnifying
Regulation
21 CFR 886.5840
Device class
Class I
Review panel
Ophthalmic
Applicant
Sing Wah International Enterprises , Ltd. 4010-4018 Jardine House,, Connaught, HK
510(k) summary
Statement
Third party review
No

Clearances, product code HOI

Trailing 12 months

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

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