NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)

Ventilator, Continuous, Facility Use

PURITAN BENNETT CORP.

The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Nellcor Puritan Bennett, 840 Ventilator System (model 840).

Pre-market Notification Details

• Device ID: K970460
• 510k Number: K970460
• Device Name: NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
• Classification: Ventilator, Continuous, Facility Use
• Applicant: PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008
• Contact: Ann-marie Butler
• Correspondent: Ann-marie Butler; PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-02-06
• Decision Date: 1998-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521515710	K970460	000
10884521181199	K970460	000
10884521183582	K970460	000
10884521210882	K970460	000
10884521210899	K970460	000
10884521658097	K970460	000
10884521515727	K970460	000
10884521077201	K970460	000
10884521132283	K970460	000
10884521083981	K970460	000
20884521810133	K970460	000
10884521076877	K970460	000
10884521181175	K970460	000
10884521181182	K970460	000
10884521181205	K970460	000
10884521712881	K970460	000
10884521077065	K970460	000
10884521076884	K970460	000
10884521181168	K970460	000
10884521181151	K970460	000
10884521750548	K970460	000
10884521076891	K970460	000
10884521076907	K970460	000
10884521076921	K970460	000
10884521076976	K970460	000
10884521076983	K970460	000
10884521076990	K970460	000
10884521077034	K970460	000
10884521077041	K970460	000
10884521077119	K970460	000
10884521077133	K970460	000
10884521077171	K970460	000
10884521180987	K970460	000
10884521181038	K970460	000
10884521181045	K970460	000
10884521181137	K970460	000
10884521181144	K970460	000
10884521076914	K970460	000
10884521076938	K970460	000
10884521181021	K970460	000
10884521181250	K970460	000
10884521183513	K970460	000
10884521183520	K970460	000
10884521183544	K970460	000
10884521183551	K970460	000
10884521183568	K970460	000
10884521211087	K970460	000
10884521211094	K970460	000
10884521211209	K970460	000
10884521211216	K970460	000
10884521211223	K970460	000
10884521211230	K970460	000
10884522019354	K970460	000
20884521083490	K970460	000
30884521084029	K970460	000
10884521148161	K970460	000
10884521181014	K970460	000
10884521181007	K970460	000
10884521076945	K970460	000
10884521077003	K970460	000
10884521077010	K970460	000
10884521077027	K970460	000
10884521077058	K970460	000
10884521077072	K970460	000
10884521077089	K970460	000
10884521077096	K970460	000
10884521077102	K970460	000
10884521077126	K970460	000
10884521077140	K970460	000
10884521077157	K970460	000
10884521077164	K970460	000
10884521077188	K970460	000
10884521077195	K970460	000
10884521077218	K970460	000
10884521180994	K970460	000
10884521101548	K970460	000