The following data is part of a premarket notification filed by International Business Strategies with the FDA for M-xx Oxygen Sensors.
| Device ID | K002384 |
| 510k Number | K002384 |
| Device Name: | M-XX OXYGEN SENSORS |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | INTERNATIONAL BUSINESS STRATEGIES 1667A MARSH HABOR LN. Mount Pleasant, SC 29464 |
| Contact | William Roettger |
| Correspondent | William Roettger INTERNATIONAL BUSINESS STRATEGIES 1667A MARSH HABOR LN. Mount Pleasant, SC 29464 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-12-15 |