FETAL DOPPLER FOR ULTRAMARK 4 AND 8— 510(k) K881329

Name: FDA 510(k) clearance K881329
Creator: U.S. Food and Drug Administration
Published: 1989-04-14

Substantially Equivalent

Advanced Technology Laboratories, Inc.

FDA 510(k) clearance K881329 for FETAL DOPPLER FOR ULTRAMARK 4 AND 8, Substantially Equivalent on 1989-04-14. Applicant: Advanced Technology Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Technology Laboratories, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1988-03-30
Decision date: 1989-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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