MICROTHERM MT-501 & MT-502— 510(k) K854007

Substantially Equivalent

Medequi, Division of King Yip Co., Inc.

FDA 510(k) clearance K854007 for MICROTHERM MT-501 & MT-502, Substantially Equivalent on 1985-11-08. Applicant: Medequi, Division of King Yip Co., Inc.. Device class: 2.

Clearance details

Applicant
Medequi, Division of King Yip Co., Inc.
Product code
Code FLL
Device class
Class 2
Regulation
21 CFR 880.2910
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Angeles, CA, US
Download summary PDFView on FDA.gov ↗

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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.