510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023238Substantially Equivalent

Mcpulse

Meridian AG, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023238 is the FDA 510(k) clearance record for MCPULSE, a class II device, cleared for Meridian Co., Ltd. on under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic). FDA records list 13 510(k) clearances for Meridian Co., Ltd., from to . As of , FDA records show no recalls naming K023238.

Clearance record

Decision date
Received
(145 days to decision)
Product code
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Regulation
21 CFR 870.2780
Device class
Class II
Review panel
Cardiovascular
Applicant
Meridian Co., Ltd. P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOM

Trailing 12 months

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

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