510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893403Substantially Equivalent

Models Hp 43110Mc, 43200Mc W/case & 43200M No Case

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

K893403 is the FDA 510(k) clearance record for MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE, a class II device, cleared for Hewlett-Packard Co. on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K893403.

Clearance record

Decision date
Received
(94 days to decision)
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
Hewlett-Packard Co. 1700 S. Baker St., Mcminnville OR
Third party review
No

Clearances, product code LDD

Trailing 12 months

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

FDA records show no clearances under product code LDD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDD, 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