The following data is part of a premarket notification filed by Mine Safety Appliances, Co. with the FDA for Miniox Ia Oxygen Analyzer.
| Device ID | K935370 |
| 510k Number | K935370 |
| Device Name: | MINIOX IA OXYGEN ANALYZER |
| Classification | Generator, Oxygen, Portable |
| Applicant | MINE SAFETY APPLIANCES, CO. P.O. BOX 427 Pittsburgh, PA 15230 |
| Contact | Thomas P Mcclory |
| Correspondent | Thomas P Mcclory MINE SAFETY APPLIANCES, CO. P.O. BOX 427 Pittsburgh, PA 15230 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-04 |
| Decision Date | 1994-08-02 |