Cleared Traditional

K061685 - PULSERA (FDA 510(k) Clearance)

K061685 · Philips Medical Systems North America Co. · Radiology device

Sep 2006

Decision

92d

Days

Class 2

Risk

K061685 is an FDA 510(k) clearance for the PULSERA. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).

Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on September 15, 2006, 92 days after receiving the submission on June 15, 2006.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K061685 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 15, 2006
Decision Date	September 15, 2006
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF