Cart, Procedures

FDA 510(k) K770438 · I E Industries

Substantially Equivalent

510(k) numberK770438

Submission

Device name
Cart, Procedures
Applicant
I E Industries
Mchenry, IL, US
Received
March 7, 1977
Decision date
July 1, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HDD – Table, Obstetrical, Ac-Powered (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4900
Specialty
Obstetrics/Gynecology

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K950889Adel 5000HDD · Traditional Stryker Corp.10/16/1995SE
K914309The Genesis Bed From Hill-Rom, Model 355 SeriesHDD · Traditional Hill-Rom, Inc.04/20/1992SE
K875123OrcepadHDD · Traditional Alton Dean Medical, Inc.06/21/1988SE
K874610Adel Model 2100 Birthing BedHDD · Traditional Adel Medical , Ltd.01/21/1988SE
K810886Adel Medical Birthing Bed, #LD-500HDD · Traditional Adel Medical , Ltd.04/23/1981SE
K771942Tilt 10, Catalog #S-2600HDD · Traditional Affiliated Hospital Products, Inc.10/27/1977SE

More from Affiliated Hospital Products, Inc.

510(k)DeviceDecision
K770636Table, Exam & ManupulationINT · Traditional 04/15/1977SE
K770437Table, ExaminationKNC · Traditional 03/23/1977SE

Questions and answers

When was Cart, Procedures cleared by the FDA?

Cart, Procedures (K770438) received a 510(k) decision of Substantially Equivalent on July 1, 1977, 116 days after the submission was received.

What is the product code of K770438?

The FDA product code is HDD – Table, Obstetrical, Ac-Powered (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.