The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Oxygen Concentration Indicator.
| Device ID | K944654 |
| 510k Number | K944654 |
| Device Name: | OXYGEN CONCENTRATION INDICATOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-21 |
| Decision Date | 1994-11-08 |