510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820416Substantially Equivalent

#505 Port. Vital Functions Neonatal Mon

GE Medical Systems Information Technologies, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820416 is the FDA 510(k) clearance record for #505 PORT. VITAL FUNCTIONS NEONATAL MON, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K820416.

Clearance record

Decision date
Received
(16 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Ge Medical Systems Information Technologies 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DRT

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