SMS GLUCOSE CONTROL, MODEL 2120061— 510(k) K070649

Substantially Equivalent

Spectrum Medical Supply, Inc.

FDA 510(k) clearance K070649 for SMS GLUCOSE CONTROL, MODEL 2120061, Substantially Equivalent on 2007-04-12. Applicant: Spectrum Medical Supply, Inc..

Clearance details

Applicant
Spectrum Medical Supply, Inc.
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seguin, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.