The following data is part of a premarket notification filed by Sensidyne, Inc. with the FDA for 100 Series Oxygen Analyzer, Models 1000-e And 1000-i.
| Device ID | K010382 |
| 510k Number | K010382 |
| Device Name: | 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | SENSIDYNE, INC. 16333 BAY VISTA DR. Clearwater, FL 33760 |
| Contact | George Mason |
| Correspondent | George Mason SENSIDYNE, INC. 16333 BAY VISTA DR. Clearwater, FL 33760 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-08 |
| Decision Date | 2001-03-01 |