Zee-Frame

FDA 510(k) K781509 · Equilibrated Bio Systems, Inc.

Substantially Equivalent

510(k) numberK781509

Submission

Device name
Zee-Frame
Applicant
Equilibrated Bio Systems, Inc.
Mchenry, IL, US
Received
September 1, 1978
Decision date
September 26, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JAY – Support, Breathing Tube
Device class
Class I (low risk)
Regulation
21 CFR 868.5280
Specialty
Anesthesiology

Other 510(k)s with product code JAY

510(k)DeviceApplicantDecision
K944988Custom Medical Suspension StrapJAY · Traditional Custom Medical Specialties, Inc.01/27/1995SE
K873491Block, Bite, IntubationJAY · Traditional B&B Medical Technologies, Inc.10/20/1987SE
K860583Dale Head Band Anesthesia Circuit Tube Holder 1315JAY · Traditional Dale Medical Products, Inc.02/21/1986SE
K850924Jee Frame (Ventilator Circuit Support)JAY · Traditional Vulcan Laboratories, Inc.07/19/1985SE
K850309Comfit Plus Endotracheal Tube Holder & Bite BlockJAY · Traditional Ackrad Laboratories02/14/1985SE
K840844Endo-SecureJAY · Traditional Exidyne, Inc.03/16/1984SE
K834265Trach MateJAY · Traditional Tempe Biomedical, Inc.01/04/1984SE
K834089ComfitJAY · Traditional Ackrad Laboratories12/29/1983SE
K833374Bite-BlockJAY · Traditional Sontek Industries, Inc.11/03/1983SE
K833361Tube-TitleJAY · Traditional Sontek Industries, Inc.11/03/1983SE

More from Sontek Industries, Inc.

510(k)DeviceDecision
K892705EBS2605 Infant HuggerBTY · Traditional 10/27/1989SE
K855102Monark 869 ErgometerDSP · Traditional 05/09/1986SE
K843996Turboaire Challanger Environmental Air ControllerBZG · Traditional 11/20/1984SE
K791294SpirocalBXX · Traditional 08/16/1979SE
K790410Adult Zee-FrameJAY · Traditional 03/22/1979SE
K781386Ebs 775 TonometerLCH · Traditional 09/14/1978SE

Questions and answers

When was Zee-Frame cleared by the FDA?

Zee-Frame (K781509) received a 510(k) decision of Substantially Equivalent on September 26, 1978, 25 days after the submission was received.

What is the product code of K781509?

The FDA product code is JAY – Support, Breathing Tube, a Class I (low risk) device regulated under 21 CFR 868.5280.