CONSUMER SENSORY PRODUCTS BIO-LOG 8000— 510(k) K904955

Substantially Equivalent

Consumer Sensory Products, Inc.

FDA 510(k) clearance K904955 for CONSUMER SENSORY PRODUCTS BIO-LOG 8000, Substantially Equivalent on 1991-04-25. Applicant: Consumer Sensory Products, Inc..

Clearance details

Applicant
Consumer Sensory Products, Inc.
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palo Alto, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

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.