ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800— 510(k) K101831

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K101831 for ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800, Substantially Equivalent on 2010-10-01. Applicant: Bionostics, Inc..

Clearance details

Applicant
Bionostics, Inc.
Product code
Code OSL
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Devens, MA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.