510(k) K092368
- Device
- REPROCESSED PULSE OXIMETER SENSORS
- Applicant
- STERILMED, INC.
- 510(k) number
- K092368
- Product code
- NLF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-03
- Date received
- 2009-08-05
- Regulation
- 870.2700
- Classification name
- Oximeter, Reprocessed
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARRETT AHLBORG
- Address
- 11400 73rd Ave. N Maple Grove MN US 55369 55369
FDA Registration Numbers#
- 1650907
- 3032391
- 1061124
- 1417592
- 9610849
- 3018094310
- 3009350690
- 3030153385
- 2936999
- 1018470
- 2032112
- 3019388613
- 3016761372
- 3011353843
- 3011024991
- 2030624
- 2011171
- 3004415095
- 3034520
- 3020163307
- 2029015
Source Documents#
Other 510(k) Records For Product Code NLF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241758 | 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) | Stryker Sustainability Solutions | 2024-10-22 |
| 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) | Stryker Sustainability Solutions | 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) | Stryker Sustainability Solutions | 2022-03-08 |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | Surgical Instrument and Savings Inc (Dba Medline Renewal) | 2020-07-22 |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Surgical Instrument Service and Savings, Inc. | 2019-07-03 |
| K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | Renu Medical, Inc. | 2011-11-16 |
| K110723 | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | Masimo Corporation | 2011-07-28 |
| K102560 | REPROCESSED PULSE OXIMETER SENSORS | Sterilmed, Inc. | 2011-02-18 |
| K101280 | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | Midwest Reprocessing Center, LLC | 2010-10-07 |
| K083719 | LNCS OXIMETRY SENSORS | Masimo Corporation | 2009-07-30 |
| K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | Renu Medical, Inc. | 2009-02-06 |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | Ascent Healthcare Solutions | 2008-07-29 |
| K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | Hygia Health Services, Inc. | 2008-05-28 |
| K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | Renu Medical, Inc. | 2007-11-29 |
| K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | Renu Medical, Inc. | 2007-05-25 |
Legacy Summary#
summary