NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

NONIN MEDICAL, INC.

The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Nonin Pulse Oximeter And Carbon Dioxide Detector, Models 9843, 9845 And 9847.

Pre-market Notification Details

• Device ID: K982969
• 510k Number: K982969
• Device Name: NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755
• Contact: Richard P Bennett
• Correspondent: Richard P Bennett; NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755
• Product Code: CCK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-08-25
• Decision Date: 1999-08-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00833166002355	K982969	000
00849686089899	K982969	000
00849686089882	K982969	000
00833166006070	K982969	000
00849686071092	K982969	000