OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

Oximeter

NELLCOR PURITAN BENNETT, INC.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Oximax Pulse Oximetry System With N-595 Pulse Oximeter And Oximax Sensors And Cables (aka Accessories).

Pre-market Notification Details

• Device ID: K012891
• 510k Number: K012891
• Device Name: OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
• Classification: Oximeter
• Applicant: NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719
• Contact: Ronald J Ehmsen
• Correspondent: Ronald J Ehmsen; NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719
• Product Code: DQA
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-28
• Decision Date: 2002-03-07
• Summary: summary

NIH GUDID Devices

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