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)— 510(k) K211138
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K211138 for 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), Substantially Equivalent on 2022-03-08. Applicant: Stryker Sustainability Solutions. Device class: 2.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- Code NLF
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Recent devices under product code NLF
view all- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
- 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)
- K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
- K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
- K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
More clearances from Stryker Sustainability Solutions
view all- K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
- K250898 — Reprocessed HARMONIC 700 Shears (3 models)
- K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) +1 more
- K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) +1 more
- K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031)
Data sourced from openFDA. This site is unofficial and independent of the FDA.