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Oximeter, Reprocessed

FDA product code NLF · 27 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2700
Review panel
AN
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2002-07-03 – 2024-10-22

same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

NLF 2022-03-08

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)

Applicant Stryker Sustainability Solutions

K number K211138

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