← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NLF — Oximeter, Reprocessed

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).

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2700
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K241758Stryker Sustainability Solutions · 510k2024-10-22

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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