PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM— 510(k) K852968

Substantially Equivalent

Personal Computers For Medicine, Inc.

FDA 510(k) clearance K852968 for PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM, Substantially Equivalent on 1985-11-14. Applicant: Personal Computers For Medicine, Inc..

Clearance details

Applicant: Personal Computers For Medicine, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1985-07-15
Decision date: 1985-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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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.