Cleared Special

K092685 - PNEUMOTHERML, MODEL: 5800
(FDA 510(k) Clearance)

K092685 · Salter Labs · Anesthesiology

Nov 2009

Decision

83d

Days

Class 2

Risk

K092685 is an FDA 510(k) clearance for the PNEUMOTHERML, MODEL: 5800, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on November 24, 2009, 83 days after receiving the submission on September 2, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K092685 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2009
Decision Date	November 24, 2009
Days to Decision	83 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF