The following data is part of a premarket notification filed by Dynotec Corp. with the FDA for Model 6323 Oxygen Concentrator.
| Device ID | K942082 |
| 510k Number | K942082 |
| Device Name: | MODEL 6323 OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | DYNOTEC CORP. 6323 NANCY RIDGE DR. San Diego, CA 92121 |
| Contact | Edward A Radtke |
| Correspondent | Edward A Radtke DYNOTEC CORP. 6323 NANCY RIDGE DR. San Diego, CA 92121 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1994-12-08 |