FDA 510(k) Premarket Notification K953974: CAMVISION 1000

Submission Details & Decision

Normalized public record details for 510(k) notification K953974.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K953974

Applicant / Sponsor

Medivision Medical Imaging, Ltd.

Device Name

CAMVISION 1000

Product Code

JAA

Decision Date

1996-09-09

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

1995-08-23

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.