Cleared Traditional

K030822 - 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS
(FDA 510(k) Clearance)

K030822 · Hans Rudolph, Inc. · Anesthesiology

Jun 2003

Decision

81d

Days

Class 2

Risk

K030822 is an FDA 510(k) clearance for the 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS. This device is classified as a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD).

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on June 3, 2003, 81 days after receiving the submission on March 14, 2003.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K030822 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2003
Decision Date	June 03, 2003
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF