EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC)

Q: What is the product code of K982754?

The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.

FDA 510(k) K982754 · A.Stein - Regulatory Affairs Consulting

Substantially Equivalent

510(k) numberK982754

Submission

Device name: EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC)
Applicant: A.Stein - Regulatory Affairs Consulting
Ginot Shomron 44853, IL
Received: August 6, 1998
Decision date: January 8, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: FWF – Camera, Television, Endoscopic, Without Audio
Device class: Class I (low risk)
Regulation: 21 CFR 878.4160
Specialty: General, Plastic Surgery

Other 510(k)s with product code FWF

510(k)	Device	Applicant	Decision
K053412	Flexiscope, Models 50MH and 50 MHCFWF · Traditional	Schoelly Imaging, Inc.	02/23/2006SE
K990154	Karl Storz Direct Coupled Interface (Dci 5) Camera SystemFWF · Traditional	Karl Storz Imaging, Inc.	06/01/1999SE
K982965	Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesFWF · Traditional	Richard Wolf Medical Instruments Corp.	11/23/1998SE
K982397	Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional	Angiolaz, Inc.	09/10/1998SE
K982409	Ves 1501-MFWF · Traditional	Angiolaz, Inc.	08/21/1998SE
K981819	Angiolaz VES-1CAMFWF · Traditional	Angiolaz, Inc.	08/04/1998SE
K944707	Isolated Camera HeadFWF · Traditional	Envision Medical Corp.	10/07/1994SE
K930297	Fujinon Video Laparoscope, ModifiedFWF · Traditional	Fujinon, Inc.	03/29/1994SE
K934682	Surgical Video Camera and AccessoriesFWF · Traditional	Medical Dynamics, Inc.	02/15/1994SE
K932628	Endoscopic Video CameraFWF · Traditional	Stephen Chakoff, Inc.	10/15/1993SE

More from Stephen Chakoff, Inc.

510(k)	Device	Decision
K972383	Easy-Jet DeviceKLZ · Traditional	11/23/1999SE
K973592	Walkcare P200 SystemJOW · Traditional	05/20/1999SE
K973590	Hemorrelief DeviceLKX · Traditional	02/05/1998SE
K973148	MacomLLZ · Traditional	11/20/1997SE

Questions and answers

When was EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC) cleared by the FDA?

EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC) (K982754) received a 510(k) decision of Substantially Equivalent on January 8, 1999, 155 days after the submission was received.

What is the product code of K982754?

The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.