510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K892354Substantially Equivalent

Odis - Obstetrical Display Info System, Hp M1370a

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

K892354 is the FDA 510(k) clearance record for ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A, 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 K892354.

Clearance record

Decision date
Received
(151 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. Schuckardstrabe 4, Germany, DE
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