Cleared Traditional

K971134 - VISTA EYESHOWER
(FDA 510(k) Clearance)

K971134 · John Branch · Anesthesiology device

Nov 1997

Decision

221d

Days

—

Risk

K971134 is an FDA 510(k) clearance for the VISTA EYESHOWER. This device is classified as a Cup, Eye.

Submitted by John Branch (Irvine, US). The FDA issued a Cleared decision on November 4, 1997, 221 days after receiving the submission on March 28, 1997.

This device falls under the Anesthesiology FDA review panel.

Submission Details

510(k) Number	K971134 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 1997
Decision Date	November 04, 1997
Days to Decision	221 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement