ULTRASONIC IMAGER— 510(k) K780876

Substantially Equivalent

Air-Shields, Inc.

FDA 510(k) clearance K780876 for ULTRASONIC IMAGER, Substantially Equivalent on 1978-06-27. Applicant: Air-Shields, Inc.. Device class: 2.

Clearance details

Applicant: Air-Shields, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1978-05-30
Decision date: 1978-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.