HOLTER SCANNER— 510(k) K881488

Name: FDA 510(k) clearance K881488
Creator: U.S. Food and Drug Administration
Published: 1988-09-20

Substantially Equivalent

Cardiodata Corp.

FDA 510(k) clearance K881488 for HOLTER SCANNER, Substantially Equivalent on 1988-09-20. Applicant: Cardiodata Corp.. Device class: 2.

Clearance details

Applicant: Cardiodata Corp.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1988-04-08
Decision date: 1988-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northborough, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cardiodata Corp.

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K900607 — MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.111990-10-16
K873337 — MODEL SSR1 HOLTER MONITOR1987-10-09
K860167 — PRODIGY AND PRODIGY PLUS1986-03-31

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.