MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
FDA 510(k) clearance K002690 · decided 2000-10-11
Clearance details
- K-number
- K002690
- Device name
- MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
- Applicant
- Nonin Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-29
- Decision date
- 2000-10-11
- Days to decision
- 43 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep ther recall (Z-1092-2008) | Respironics, Inc. | 2008-04-24 |
| Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA recall (Z-0843-2008) | Nonin Medical, Inc | 2008-04-11 |