ULTRASOUND B-SCANNING SYSTEM— 510(k) K770644

Substantially Equivalent

Unirad Corp.

FDA 510(k) clearance K770644 for ULTRASOUND B-SCANNING SYSTEM, Substantially Equivalent on 1977-04-14. Applicant: Unirad Corp.. Device class: 2.

Clearance details

Applicant: Unirad Corp.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1977-04-04
Decision date: 1977-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER1991-01-31
K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNER1990-08-10

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