Cleared Traditional

KNIGHTSTAR 335

K973004 · Puritan Bennett Corp. · Anesthesiology

Jul 1998

Decision

337d

Days

Class 2

Risk

About This 510(k) Submission

K973004 is an FDA 510(k) clearance for the KNIGHTSTAR 335, a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II — Special Controls, product code MNT), submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on July 16, 1998, 337 days after receiving the submission on August 13, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K973004 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 1997
Decision Date	July 16, 1998
Days to Decision	337 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5895