VSM R1— 510(k) K842213

Name: FDA 510(k) clearance K842213
Creator: U.S. Food and Drug Administration
Published: 1984-10-26

Substantially Equivalent

Physio-Control Corp.

FDA 510(k) clearance K842213 for VSM R1, Substantially Equivalent on 1984-10-26. Applicant: Physio-Control Corp.. Device class: 2.

Clearance details

Applicant: Physio-Control Corp.
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
Advisory panel: Cardiovascular
Date received: 1984-06-04
Decision date: 1984-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXO

view all

K251367 — OptoMonitor 32026-01-16
K241418 — OptoMonitor 32025-02-12
K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_2024-07-17
K222216 — TruWave Disposable Pressure Transducer2022-12-22
K202943 — OptoMonitor 32020-11-24

More clearances from Physio-Control Corp.

view all

K991910 — LIFEPAK 12 BIPHASIC1999-09-03
K990338 — NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM1999-09-01
K983393 — LIFEPAK 500 BIPHASIC1999-05-05
K973486 — LIFE PAK 121998-01-09
K962359 — LIFEPAK 3001997-11-06

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.