The following data is part of a premarket notification filed by Mine Safety Appliances, Co. with the FDA for Miniox 3000 Oxygen Monitor.
| Device ID | K961644 |
| 510k Number | K961644 |
| Device Name: | MINIOX 3000 OXYGEN MONITOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MINE SAFETY APPLIANCES, CO. 300 WALDEN RD. Mars, PA 16066 |
| Contact | Thomas P Mcclory |
| Correspondent | Thomas P Mcclory MINE SAFETY APPLIANCES, CO. 300 WALDEN RD. Mars, PA 16066 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-29 |
| Decision Date | 1996-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08688250002566 | K961644 | 000 |
| 00628101609184 | K961644 | 000 |
| 00628101609207 | K961644 | 000 |
| 00628101609467 | K961644 | 000 |
| 00628101609474 | K961644 | 000 |
| 00628101609481 | K961644 | 000 |
| 08688250002153 | K961644 | 000 |
| 08688250002184 | K961644 | 000 |
| 08688250002214 | K961644 | 000 |
| 08688250002542 | K961644 | 000 |
| 08688250002559 | K961644 | 000 |
| 00628101609153 | K961644 | 000 |