NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM

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, 760 Ventilator System.

Pre-market Notification Details

• Device ID: K984379
• 510k Number: K984379
• Device Name: NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
• Classification: Ventilator, Continuous, Facility Use
• Applicant: PURITAN BENNETT CORP. MERVUE Galway, IE
• Contact: Robbie Walsh
• Correspondent: Robbie Walsh; PURITAN BENNETT CORP. MERVUE Galway, IE
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-12-07
• Decision Date: 1998-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521182851	K984379	000
10884521182813	K984379	000
10884521180963	K984379	000
10884521180949	K984379	000
10884521180925	K984379	000
10884521180918	K984379	000
10884521180956	K984379	000
10884521180932	K984379	000
10884521180970	K984379	000