510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150632Substantially Equivalent

Hypervisor IX Monitoring System

Shenzhen Mindray Bio-Medical Electronics Co.,LTD, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150632 is the FDA 510(k) clearance record for Hypervisor IX Monitoring System, a class II device, cleared for Shenzhen Mindray Bio-Medical Electronics Co., Ltd. on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list 160 510(k) clearances for Shenzhen Mindray Bio-Medical Electronics Co., Ltd., from to . As of , FDA records show 2 recalls naming K150632.

Clearance record

Decision date
Received
(117 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Bldg., Kenji 12th Rd. S.,, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSX

Trailing 12 months
4 clearances under product code MSX in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20261
August 20261
September 20261
October 20260