Cleared Traditional

K813002 - MAVIS C (FDA 510(k) Clearance)

K813002 · Philips Medical Systems (Cleveland), Inc. · Radiology device

Mar 1982

Decision

126d

Days

Class 2

Risk

K813002 is an FDA 510(k) clearance for the MAVIS C. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982, 126 days after receiving the submission on October 26, 1981.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.2330.

Submission Details

510(k) Number	K813002 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 26, 1981
Decision Date	March 01, 1982
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—

Device Classification

Product Code	DXK — Echocardiograph
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 870.2330