FDA 510(k) Premarket Notification K033956: MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)

Submission Details & Decision

Normalized public record details for 510(k) notification K033956.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K033956

Applicant / Sponsor

Is2 Research, Inc.

Device Name

MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)

Product Code

KPS

Decision Date

2004-01-20

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Special

Third Party Flag

Date Received

2003-12-22

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