CATEGORY 1 CIRCULATORY SYSTEM DEVICE— 510(k) K840305

Name: FDA 510(k) clearance K840305
Creator: U.S. Food and Drug Administration
Published: 1984-04-23

Substantially Equivalent

Imm Enterprises , Ltd.

FDA 510(k) clearance K840305 for CATEGORY 1 CIRCULATORY SYSTEM DEVICE, Substantially Equivalent on 1984-04-23. Applicant: Imm Enterprises , Ltd.. Device class: 1.

Clearance details

Applicant: Imm Enterprises , Ltd.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1984-01-24
Decision date: 1984-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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