Healthpak X-Ray Sox Barriers

Q: What is the product code of K923307?

The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.

FDA 510(k) K923307 · Healthpak, Inc.

Substantially Equivalent

510(k) numberK923307

Submission

Device name: Healthpak X-Ray Sox Barriers
Applicant: Healthpak, Inc.
Chicago, IL, US
Received: May 8, 1992
Decision date: January 21, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EAP – Unit, X-Ray, Intraoral
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.1810
Specialty: Dental

Other 510(k)s with product code EAP

510(k)	Device	Applicant	Decision
K113360	Medical Image Processing UnitEAP · Special	Humanray Co,Ltd	02/07/2012SE
K102573	Provu (TM) Dental X-Ray SystemEAP · Traditional	Advanced Image Science, Inc.	06/30/2011SE
K093453	Modification to Computed Oral Radiology SystemEAP · Special	Schick Technologies, Inc.	11/30/2009SE
K080738	Dentron SensorEAP · Traditional	Dentron Systems, LLC	05/13/2008SE
K052422	The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special	Flow X-Ray Corp.	09/27/2005SE
K041385	Modification to Computed Oral Radiology SystemEAP · Special	Schick Technologies, Inc.	06/07/2004SE
K960819	Heliodent DSEAP · Traditional	Pelton & Crane Co.	03/29/1996SE
K960028	Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional	Dentsply Intl.	03/01/1996SE
K953936	AtlantisEAP · Traditional	Trophy Radiologie	12/28/1995SE
K954565	Explor-X (Azteh) HFEAP · Traditional	Chicago X-Ray Systems, Inc.	10/27/1995SE

More from Chicago X-Ray Systems, Inc.

510(k)	Device	Decision
K922175	Healthpak Chair Sox BarriersKLC · Traditional	08/06/1992SE
K923306	Healthpak Utility Sox BarriersKLC · Traditional	08/05/1992SE
K920052	Health Pak Tray Sox BarriersKKX · Traditional	04/03/1992SE

Questions and answers

When was Healthpak X-Ray Sox Barriers cleared by the FDA?

Healthpak X-Ray Sox Barriers (K923307) received a 510(k) decision of Substantially Equivalent on January 21, 1993, 258 days after the submission was received.

What is the product code of K923307?

The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.