The following data is part of a premarket notification filed by Sharp Corporation with the FDA for Pultol.
| Device ID | K113865 |
| 510k Number | K113865 |
| Device Name: | PULTOL |
| Classification | Oximeter |
| Applicant | SHARP CORPORATION 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford SHARP CORPORATION 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-03-21 |
| Summary: | summary |