The following data is part of a premarket notification filed by Clear Medical, Inc. with the FDA for Clearmedical/nellcor Oxisensor Ii, Neonatal/adult, Model N-25.
| Device ID | K012609 |
| 510k Number | K012609 |
| Device Name: | CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 |
| Classification | Oximeter, Reprocessed |
| Applicant | CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue, WA 98005 |
| Contact | Richard Radford |
| Correspondent | Richard Radford CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue, WA 98005 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2002-07-03 |
| Summary: | summary |