The following data is part of a premarket notification filed by International Business Strategies with the FDA for Sp02 Sensor Fs And Ps 'silc-touch' Series; Sp02 Sensor Fc, Fp And Y Series.
| Device ID | K062149 |
| 510k Number | K062149 |
| Device Name: | SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES |
| Classification | Oximeter |
| Applicant | INTERNATIONAL BUSINESS STRATEGIES 1667A MARSH HABOR LN. Mount Pleasant, SC 29464 |
| Contact | Bill Roettger |
| Correspondent | Bill Roettger INTERNATIONAL BUSINESS STRATEGIES 1667A MARSH HABOR LN. Mount Pleasant, SC 29464 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-27 |
| Decision Date | 2007-05-31 |
| Summary: | summary |