510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K942887Substantially Equivalent

Model M1310a, Series 50T Fetal Telemetry System

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

K942887 is the FDA 510(k) clearance record for MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM, a class II device, cleared for Hewlett-Packard Co. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K942887.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hewlett-Packard Co. 175 Waltham St., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code HGM

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