NICE PACK— 510(k) K832193

Substantially Equivalent

Universal Medical Instrument Corp.

FDA 510(k) clearance K832193 for NICE PACK, Substantially Equivalent on 1983-08-31. Applicant: Universal Medical Instrument Corp..

Clearance details

Applicant
Universal Medical Instrument Corp.
Product code
Code IME
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code IME

product code IME
Other
1
Total
1

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.