510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922058Substantially Equivalent

Models M1175a and M1176a Component Monitoring Syst

Hewlett-Packard Co., Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922058 is the FDA 510(k) clearance record for MODELS M1175A AND M1176A COMPONENT MONITORING SYST, a class II device, cleared for Hewlett-Packard Co. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K922058.

Clearance record

Decision date
Received
(167 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Hewlett-Packard Co. Schuckardstrabe 4, Germany, DE
510(k) summary
Summary
Third party review
No

Clearances, product code MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to November 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20261
November 20260