The following data is part of a premarket notification filed by Sensidyne, Inc. with the FDA for Sensidyne Oxygen Analyzer & Sensidyne Oxygen Monitor.
| Device ID | K000700 |
| 510k Number | K000700 |
| Device Name: | SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | SENSIDYNE, INC. 16333 BAY VISTA DR. Clearwater, FL 33760 |
| Contact | Howard Mills |
| Correspondent | Howard Mills SENSIDYNE, INC. 16333 BAY VISTA DR. Clearwater, FL 33760 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-01 |
| Decision Date | 2000-08-31 |