FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LIFESTAT 200

K Number: K831232 · Decision Jul 28, 1983
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
80
Review Days
104

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
LIFESTAT 200
K Number
K831232
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1130
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Physio-Control Corp.
Date Received
April 15, 1983
Decision Date
July 28, 1983
Product Code
DXN
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DXN System, Measurement, Blood-Pressure, Non-Invasive

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.

View all

Other Clearances by Physio-Control Corp.

K Number Device Name
K991910 LIFEPAK 12 BIPHASIC
K990338 NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
K983393 LIFEPAK 500 BIPHASIC
K973486 LIFE PAK 12
K962359 LIFEPAK 300
K955854 LIFEPAK 500
K953204 PEDIATRIC QUIK-COMBO
K951593 LIFEPAK 11
K945511 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
K943301 QUIK COMBO
Search all 80 clearances from Physio-Control Corp. →