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K Number
K982754
Device Name
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
Manufacturer
A. STEIN - REGULATORY AFFAIRS CONSULTING
Date Cleared
1999-01-08

(155 days)

Product Code
FWF
Regulation Number
878.4160
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EC 1000-7 Digital Endoscopy Video Camera is a device used for monitoring and recording during endoscopic procedures.

Device Description

EC 1000-7 Digital Endoscopy Video Camera (Models EC 1000-7P (PAL) & EC 1000-7 (NTSC))

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the EC 1000-7 Digital Endoscopy Video Camera. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The text is a regulatory clearance and not a scientific or clinical study report.

§ 878.4160 Surgical camera and accessories.

(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.