Innervision Irrigation Pump

FDA 510(k) K910982 · M.D. Engineering, Inc.

Substantially Equivalent

510(k) numberK910982

Submission

Device name
Innervision Irrigation Pump
Applicant
M.D. Engineering, Inc.
Hayward, CA, US
Received
March 7, 1991
Decision date
August 26, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K920985Snowden-Pencer Irrigation PumpHEI · Traditional Snowden-Pencer06/09/1992SE

More from Snowden-Pencer

510(k)DeviceDecision
K912882Innervision Laparoscope and AccessoriesHET · Traditional 01/24/1992SE
K910983IV 1000 Insufflator Rapid FlowHIF · Traditional 12/09/1991SE
K883384TS1000 Suction TipBSY · Traditional 11/02/1988SE

Questions and answers

When was Innervision Irrigation Pump cleared by the FDA?

Innervision Irrigation Pump (K910982) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 172 days after the submission was received.

What is the product code of K910982?

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