SUZANNE

Ventilatory Effort Recorder

NELLCOR PURITAN BENNETT, INC.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Suzanne.

Pre-market Notification Details

• Device ID: K990565
• 510k Number: K990565
• Device Name: SUZANNE
• Classification: Ventilatory Effort Recorder
• Applicant: NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 -2625
• Contact: Darin Busch
• Correspondent: Darin Busch; NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 -2625
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-22
• Decision Date: 1999-08-18
• Summary: summary