MICRO MEDICAL DATA SYSTEM II— 510(k) K800242

Substantially Equivalent

Micro/Tel., Inc.

FDA 510(k) clearance K800242 for MICRO MEDICAL DATA SYSTEM II, Substantially Equivalent on 1980-03-03. Applicant: Micro/Tel., Inc.. Device class: 1.

Clearance details

Applicant
Micro/Tel., Inc.
Product code
Code JQP
Device class
Class 1
Regulation
21 CFR 862.2100
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JQP

product code JQP
Death
3
Malfunction
690
Total
693

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.