Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)

K-Number: K982754 · 1999-01-08

ApplicantA.Stein - Regulatory Affairs Consulting
Decision Date1999-01-08
Product CodeFWF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) is the device name listed in this FDA 510(k) record. The listed applicant is A.Stein - Regulatory Affairs Consulting. It received FDA 510(k) clearance on 1999-01-08 under 510(k) number K982754. The device is classified under product code FWF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)?

EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) is a medical device that received FDA 510(k) clearance on 1999-01-08. The listed applicant is A.Stein - Regulatory Affairs Consulting. The 510(k) number is K982754.

When did EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) receive FDA 510(k) clearance?

EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) received FDA 510(k) clearance on 1999-01-08, under 510(k) number K982754.

Who is the listed applicant for EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)?

The FDA 510(k) record lists A.Stein - Regulatory Affairs Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)?

The FDA product code for EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) is FWF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing A.Stein - Regulatory Affairs Consulting as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972383EASY-JET DEVICEK973592WALKCARE P200 SYSTEMK973590HEMORRELIEF DEVICEK973148MACOM

Related Devices (Code: FWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053412FLEXISCOPE, MODELS 50MH AND 50 MHCSchoelly Imaging, Inc.K990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMKarl Storz Imaging, Inc.K982965ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIESRichard Wolf Medical Instruments Corp.K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMAngiolaz, Inc.K982409VES 1501-MAngiolaz, Inc.K981819ANGIOLAZ VES-1CAMAngiolaz, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑