CIRCADIAN STRESS TEST II— 510(k) K874641

Substantially Equivalent

Circadian, Inc.

FDA 510(k) clearance K874641 for CIRCADIAN STRESS TEST II, Substantially Equivalent on 1988-04-01. Applicant: Circadian, Inc..

Clearance details

Applicant
Circadian, Inc.
Product code
Code DPS
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DPS

product code DPS
Death
7
Total
7

Source: openFDA MAUDE database, through . 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.