POCKETCPR— 510(k) K071321

Substantially Equivalent

Bio-Detek, Inc.

FDA 510(k) clearance K071321 for POCKETCPR, Substantially Equivalent on 2007-09-12. Applicant: Bio-Detek, Inc..

Clearance details

Applicant: Bio-Detek, Inc.
Product code: Code LIX
Advisory panel: Cardiovascular
Date received: 2007-05-10
Decision date: 2007-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pawtucket, RI, US

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Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.