The following data is part of a premarket notification filed by Konica Minolta Sensing, Inc. with the FDA for Konica Minolta Pulsox-300, 300i.
| Device ID | K053419 |
| 510k Number | K053419 |
| Device Name: | KONICA MINOLTA PULSOX-300, 300I |
| Classification | Oximeter |
| Applicant | KONICA MINOLTA SENSING, INC. 2703 JOSEPHINE ST. Denver, CO 80205 |
| Contact | Nanci Dexter |
| Correspondent | Nanci Dexter KONICA MINOLTA SENSING, INC. 2703 JOSEPHINE ST. Denver, CO 80205 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-08 |
| Decision Date | 2006-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770021001 | K053419 | 000 |
| 04571237523663 | K053419 | 000 |
| 04571237524134 | K053419 | 000 |
| 04571237524189 | K053419 | 000 |
| 00817770020530 | K053419 | 000 |
| 00817770020547 | K053419 | 000 |
| 00817770020554 | K053419 | 000 |
| 00817770020578 | K053419 | 000 |
| 00817770020585 | K053419 | 000 |
| 00817770020608 | K053419 | 000 |
| 00817770020615 | K053419 | 000 |
| 00817770020622 | K053419 | 000 |
| 00817770020639 | K053419 | 000 |
| 00817770020646 | K053419 | 000 |
| 00817770020653 | K053419 | 000 |
| 04571237523441 | K053419 | 000 |