MULTICHANNEL TELEMETRY SYSTEM— 510(k) K801944

Substantially Equivalent

Burdick Corp.

FDA 510(k) clearance K801944 for MULTICHANNEL TELEMETRY SYSTEM, Substantially Equivalent on 1980-10-23. Applicant: Burdick Corp.. Device class: 2.

Clearance details

Applicant
Burdick Corp.
Product code
Code DRG
Device class
Class 2
Regulation
21 CFR 870.2910
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DRG

product code DRG
Death
5
Total
5

Source: openFDA MAUDE database, through . 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.