SEAMED, #540 - SIEMENS, #146F TELECTRO— 510(k) K820570

Name: FDA 510(k) clearance K820570
Creator: U.S. Food and Drug Administration
Published: 1982-06-03

Substantially Equivalent

Seamed Corp.

FDA 510(k) clearance K820570 for SEAMED, #540 - SIEMENS, #146F TELECTRO, Substantially Equivalent on 1982-06-03. Applicant: Seamed Corp.. Device class: 2.

Clearance details

Applicant: Seamed Corp.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 1982-03-02
Decision date: 1982-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Seamed Corp.

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K912507 — CPI MODEL 2215 & SEAMED MODEL 34001991-09-03
K910223 — CPI MODEL 2215/SEAMED MODEL 34001991-03-19
K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY1988-11-09

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.