Clearance Summary
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) received FDA 510(k) clearance under submission number K982754, sponsored by A.Stein - Regulatory Affairs Consulting. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1999-01-08.
- Submission: K982754
- Applicant / Sponsor: A.Stein - Regulatory Affairs Consulting
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1999-01-08
Classification & Regulation
This clearance is catalogued under FDA product code FWF and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.