Dopplex-Plb & PXB

FDA 510(k) K810115 · Huntleigh Technology, Inc.

Substantially Equivalent

510(k) numberK810115

Submission

Device name
Dopplex-Plb & PXB
Applicant
Huntleigh Technology, Inc.
Walker, MI, US
Received
January 16, 1981
Decision date
July 16, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNG – Monitor, Ultrasonic, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

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More from Shenzzhen Luckcome Technology Inc., Ltd.

510(k)DeviceDecision
K992733Akron ATP9 Traction MachineITH · Traditional 11/10/1999SE
K964699Rheo Dopplex II (RD 2)IYN · Traditional 02/21/1997SE
K924516OP3/VP4HGL · Traditional 06/28/1993SE
K910188Flowplus AC330 Pump GarmentsJOW · Traditional 05/28/1991SE
K900882Multi Dopplex, MD-1JAF · Traditional 08/22/1990SE
K900618Huntleigh Fetal Doppler, FD-1 & Dopcord, D140KNG · Traditional 04/25/1990SE
K890012Huntleigh Dynamic Flotation SystemFNM · Traditional 03/29/1989SE
K884451Dopcord PPGJOM · Traditional 01/12/1989SE
K881632Flowtron DVT System AC500 Pump, L501 GarmentJOW · Traditional 09/26/1988SE
K874688Flowtron AC200/2IRP · Traditional 09/23/1988SE

Questions and answers

When was Dopplex-Plb & PXB cleared by the FDA?

Dopplex-Plb & PXB (K810115) received a 510(k) decision of Substantially Equivalent on July 16, 1981, 181 days after the submission was received.

What is the product code of K810115?

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