Decision Date2007-11-29
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 is the device name listed in this FDA 510(k) record. The listed applicant is Renu Medical, Inc.. It received FDA 510(k) clearance on 2007-11-29 under 510(k) number K072194. The device is classified under product code NLF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25?
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 is a medical device that received FDA 510(k) clearance on 2007-11-29. The listed applicant is Renu Medical, Inc.. The 510(k) number is K072194.
When did RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 receive FDA 510(k) clearance?
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 received FDA 510(k) clearance on 2007-11-29, under 510(k) number K072194.
Who is the listed applicant for RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25?
The FDA 510(k) record lists Renu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25?
The FDA product code for RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 is NLF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.