Cleared Traditional

SNOWDEN-PENCER IRRIGATION PUMP

K920985 · Snowden-Pencer · Obstetrics & Gynecology
Jun 1992
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K920985 is an FDA 510(k) clearance for the SNOWDEN-PENCER IRRIGATION PUMP, a Monitor, Heart-valve Movement, Fetal, Ultrasonic (Class II — Special Controls, product code HEI), submitted by Snowden-Pencer (Tucker, US). The FDA issued a Cleared decision on June 9, 1992, 99 days after receiving the submission on March 2, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K920985 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1992
Decision Date June 09, 1992
Days to Decision 99 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HEI — Monitor, Heart-valve Movement, Fetal, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2660