CUE FERTILITY MONITOR— 510(k) K850579

Substantially Equivalent

Zetek, Inc.

FDA 510(k) clearance K850579 for CUE FERTILITY MONITOR, Substantially Equivalent on 1985-03-22. Applicant: Zetek, Inc.. Device class: 1.

Clearance details

Applicant: Zetek, Inc.
Product code: Code NGE
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1985-02-13
Decision date: 1985-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Recent devices under product code NGE

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K981207 — CLEARPLAN EASY FERTILITY MONITOR1998-10-28
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K863121 — PEAK OVULATION PREDICTOR1986-10-14

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