510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863494Substantially Equivalent

Neonatal Physiological Monitor Model Pm 20

Advantage Medical Systems, Inc., Hamden CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863494 is the FDA 510(k) clearance record for NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20, a class II device, cleared for Advantage Medical Systems, Inc. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 17 510(k) clearances for Advantage Medical Systems, Inc., from to . As of , FDA records show no recalls naming K863494.

Clearance record

Decision date
Received
(104 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
Advantage Medical Systems, Inc. 925 Sherman Ave., Hamden CT
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