RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25— 510(k) K072194

Clearance details

Applicant

Renu Medical, Inc.

Product code

Code NLF

Device class

Class 2

Regulation

21 CFR 870.2700

Advisory panel

Cardiovascular

Date received

2007-08-07

Decision date

2007-11-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Everett, WA, US

• K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more2024-10-22
• K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)2022-12-04
• K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)2022-03-08
• K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor2020-07-22
• K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors2019-07-03

• K203847 — Reprocessed Tri Pulse Compression Garment2021-05-07
• K121145 — RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME2012-06-12
• K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE2011-11-16
• K093658 — RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS2010-01-14
• K081927 — RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO2009-02-06