510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K963576Substantially Equivalent

Mobile Medical Monitor (M3(a))

Scientific Applications, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963576 is the FDA 510(k) clearance record for MOBILE MEDICAL MONITOR (M3(A)), a class II device, cleared for Scientific Applications on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list one 510(k) clearance for Scientific Applications. As of , FDA records show no recalls naming K963576.

Clearance record

Decision date
Received
(175 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
Scientific Applications 4224 Campus Pt. Ct., San Diego CA
510(k) summary
Summary
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