NDM INFANT ECG PACKPAD— 510(k) K780631

Name: FDA 510(k) clearance K780631
Creator: U.S. Food and Drug Administration
Published: 1978-05-03

Substantially Equivalent

New Dimensions IN Medicine, Inc.

FDA 510(k) clearance K780631 for NDM INFANT ECG PACKPAD, Substantially Equivalent on 1978-05-03. Applicant: New Dimensions IN Medicine, Inc.. Device class: 2.

Clearance details

Applicant: New Dimensions IN Medicine, Inc.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1978-04-17
Decision date: 1978-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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