Cleared Traditional

S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM

K030797 · ResMed Corp · Anesthesiology

Mar 2004

Decision

363d

Days

Class 2

Risk

About This 510(k) Submission

K030797 is an FDA 510(k) clearance for the S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (Poway, US). The FDA issued a Cleared decision on March 10, 2004, 363 days after receiving the submission on March 13, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K030797 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2003
Decision Date	March 10, 2004
Days to Decision	363 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF