510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K950483Substantially Equivalent

Hewlett Packard M2475b Codemaster 100 Defibrillator/monitor

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

K950483 is the FDA 510(k) clearance record for HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR, a class II device, cleared for Hewlett-Packard Co. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K950483.

Clearance record

Decision date
Received
(108 days to decision)
Product code
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Applicant
Hewlett-Packard Co. 1700 S. Baker St., Mcminnville OR
510(k) summary
Summary
Third party review
No

Clearances, product code DRO

Trailing 12 months

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

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