RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25

Oximeter, Reprocessed

RENU MEDICAL, INC.

The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25.

Pre-market Notification Details

• Device ID: K072194
• 510k Number: K072194
• Device Name: RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
• Classification: Oximeter, Reprocessed
• Applicant: RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204
• Contact: Bruce Pierson
• Correspondent: Bruce Pierson; RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204
• Product Code: NLF
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-07
• Decision Date: 2007-11-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10861317020528	K072194	000
10816317020528	K072194	000