Cleared Special

K071955 - WIM-PC, MODEL 1010
(FDA 510(k) Clearance)

K071955 · Karmelsonix · Anesthesiology

Nov 2007

Decision

108d

Days

Class 2

Risk

K071955 is an FDA 510(k) clearance for the WIM-PC, MODEL 1010. This device is classified as a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II — Special Controls, product code BZM).

Submitted by Karmelsonix (Binyamina, IL). The FDA issued a Cleared decision on November 1, 2007, 108 days after receiving the submission on July 16, 2007.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number	K071955 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2007
Decision Date	November 01, 2007
Days to Decision	108 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF