SELECTATEC SYSTEM— 510(k) K760668

Substantially Equivalent

Medishield, Inc.

FDA 510(k) clearance K760668 for SELECTATEC SYSTEM, Substantially Equivalent on 1976-09-27. Applicant: Medishield, Inc.. Device class: 2.

Clearance details

Applicant
Medishield, Inc.
Product code
Code CAD
Device class
Class 2
Regulation
21 CFR 868.5880
Advisory panel
Anesthesiology
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 CAD

product code CAD
Malfunction
3,275
Total
3,275

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.