Ross-Emerson Pump, Model 55-R

FDA 510(k) K811779 · J. H. Emerson Co.

Substantially Equivalent

510(k) numberK811779

Submission

Device name
Ross-Emerson Pump, Model 55-R
Applicant
J. H. Emerson Co.
Mchenry, IL, US
Received
June 23, 1981
Decision date
July 13, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KQT – Evacuator, Gastro-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4370
Specialty
Gastroenterology, Urology

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K830546Dosimetric ReleaseKQT · Traditional American Hospital Supply Corp.05/25/1983SE
K810739Suction Wound Drainage DeviceKQT · Traditional The Urology Group06/26/1981SE
K801782General Purpose Irrigating/Aspir Syr.KQT · Traditional The Healthcare Group Laboratories, Inc.08/13/1980SE

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K896721Model 7-AT Treatment ChamberLGM · Traditional 01/22/1990SE
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K873489Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional 12/29/1987SE
K87293797-TD Emerson Timer/Dimmer ControlIQA · Traditional 09/24/1987SE
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Questions and answers

When was Ross-Emerson Pump, Model 55-R cleared by the FDA?

Ross-Emerson Pump, Model 55-R (K811779) received a 510(k) decision of Substantially Equivalent on July 13, 1981, 20 days after the submission was received.

What is the product code of K811779?

The FDA product code is KQT – Evacuator, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.4370.