MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

Oximeter, Reprocessed

STERILMED, INC.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Modification To: Reprocessed Oximax Pulse Oximeter Sensors.

Pre-market Notification Details

• Device ID: K041127
• 510k Number: K041127
• Device Name: MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
• Classification: Oximeter, Reprocessed
• Applicant: STERILMED, INC. 11400 73RD AVE. NORTH Minneapolis, MN 55369
• Contact: Bruce Lester
• Correspondent: Bruce Lester; STERILMED, INC. 11400 73RD AVE. NORTH Minneapolis, MN 55369
• Product Code: NLF
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-30
• Decision Date: 2004-09-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20888551042540	K041127	000
20888551042533	K041127	000
20888551042359	K041127	000
20888551042342	K041127	000
20888551042151	K041127	000
20888551042144	K041127	000
20888551042137	K041127	000
20888551042120	K041127	000
20888551042113	K041127	000