Snowden-Pencer Irrigation Pump

FDA 510(k) K920985 · Snowden-Pencer

Substantially Equivalent

510(k) numberK920985

Submission

Device name
Snowden-Pencer Irrigation Pump
Applicant
Snowden-Pencer
Tucker, GA, US
Received
March 2, 1992
Decision date
June 9, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HEI – Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HEI

510(k)DeviceApplicantDecision
K012003DRG Reaction Chamber/Safety TipHEI · Traditional Doctor'S Research Group, Inc.02/12/2002SE
K910982Innervision Irrigation PumpHEI · Traditional M.D. Engineering, Inc.08/26/1991SE

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K920986Snowden-Pencer High Flow Insufflator, SP/88-9700HIF · Traditional 06/04/1992SE
K913979Endo I/A Y SetHIF · Traditional 11/27/1991SE
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Questions and answers

When was Snowden-Pencer Irrigation Pump cleared by the FDA?

Snowden-Pencer Irrigation Pump (K920985) received a 510(k) decision of Substantially Equivalent on June 9, 1992, 99 days after the submission was received.

What is the product code of K920985?

The FDA product code is HEI – Monitor, Heart-Valve Movement, Fetal, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.