MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120— 510(k) K002787

Substantially Equivalent

Palco Labs, Inc.

FDA 510(k) clearance K002787 for MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120, Substantially Equivalent on 2000-11-29. Applicant: Palco Labs, Inc..

Clearance details

Applicant: Palco Labs, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2000-09-07
Decision date: 2000-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Cruz, CA, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.