CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS— 510(k) K900814

Substantially Equivalent

Intellimetrics Instrument Corp.

FDA 510(k) clearance K900814 for CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS, Substantially Equivalent on 1990-12-17. Applicant: Intellimetrics Instrument Corp..

Clearance details

Applicant: Intellimetrics Instrument Corp.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1990-02-21
Decision date: 1990-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.