MDP2000 MEDICAL DATA PROCESSOR— 510(k) K972880

Name: FDA 510(k) clearance K972880
Creator: U.S. Food and Drug Administration
Published: 1997-10-22

Substantially Equivalent

Vidco, Inc.

FDA 510(k) clearance K972880 for MDP2000 MEDICAL DATA PROCESSOR, Substantially Equivalent on 1997-10-22. Applicant: Vidco, Inc.. Device class: 2.

Clearance details

Applicant: Vidco, Inc.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1997-08-05
Decision date: 1997-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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 →

Recalls naming K972880

K-number listed on FDA's recall record

Z-0582-2016 — Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously.Class II·Terminated·Vidco, Inc.·20151108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972880.

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