The following data is part of a premarket notification filed by Konica Minolta Sensing, Inc. with the FDA for Minolta Pulsox-3si, Pulsox-3ia, Pulsox-3li.
| Device ID | K010413 |
| 510k Number | K010413 |
| Device Name: | MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI |
| Classification | Oximeter |
| Applicant | KONICA MINOLTA SENSING, INC. 458 S. RANDOM RD. Bailey, CO 80421 |
| Contact | Nanci Dexter |
| Correspondent | Nanci Dexter KONICA MINOLTA SENSING, INC. 458 S. RANDOM RD. Bailey, CO 80421 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-12 |
| Decision Date | 2001-08-02 |