Cleared Traditional

K952756 - MEDI-AID BASAL THERMOMETER (FDA 510(k) Clearance)

Sep 1995
Decision
101d
Days
Risk

K952756 is an FDA 510(k) clearance for the MEDI-AID BASAL THERMOMETER. This device is classified as a Device, Fertility Diagnostic, Proceptive.

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on September 25, 1995, 101 days after receiving the submission on June 16, 1995.

This device falls under the Obstetrics & Gynecology FDA review panel.

Submission Details

510(k) Number K952756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1995
Decision Date September 25, 1995
Days to Decision 101 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code LHD — Device, Fertility Diagnostic, Proceptive
Device Class