Atlas FDA

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

FDA 510(k) clearance K072194 · decided 2007-11-29

Clearance details

K-number
K072194
Device name
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
Applicant
Renu Medical, Inc.
Decision
Substantially Equivalent
Date received
2007-08-07
Decision date
2007-11-29
Days to decision
114 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Everett, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.