Cleared Special

K014056 - SALTER LABS MODIFIED NEBUTECH NEBULIZER
(FDA 510(k) Clearance)

K014056 · Salter Labs · Anesthesiology

Feb 2002

Decision

53d

Days

Class 2

Risk

K014056 is an FDA 510(k) clearance for the SALTER LABS MODIFIED NEBUTECH NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on February 1, 2002, 53 days after receiving the submission on December 10, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K014056 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2001
Decision Date	February 01, 2002
Days to Decision	53 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF