The following data is part of a premarket notification filed by Digiflo, Inc. with the FDA for Digiflo Concentrator Analyzer.
| Device ID | K072469 |
| 510k Number | K072469 |
| Device Name: | DIGIFLO CONCENTRATOR ANALYZER |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | DIGIFLO, INC. 6942 96TH AVE. SE Mercer Island, WA 98040 |
| Contact | Mike Stern |
| Correspondent | Mike Stern DIGIFLO, INC. 6942 96TH AVE. SE Mercer Island, WA 98040 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-04 |
| Decision Date | 2008-01-03 |
| Summary: | summary |