510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920429Substantially Equivalent

Modified Model M1403a Telemetry Monitoring System

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

K920429 is the FDA 510(k) clearance record for MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM, a class II device, cleared for Hewlett-Packard Co. on under FDA product code MLD (Monitor, St Segment With Alarm). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K920429.

Clearance record

Decision date
Received
(533 days to decision)
Product code
MLD Monitor, St Segment With Alarm
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Hewlett-Packard Co. 175 Waltham St., Waltham MA
510(k) summary
Statement
Third party review
No

Clearances, product code MLD

Trailing 12 months

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

FDA records show no clearances under product code MLD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260