The following data is part of a premarket notification filed by Micro Direct, Inc. with the FDA for Micro H2 Breath Monitoring Device With Hydra Software Utility.
| Device ID | K033688 |
| 510k Number | K033688 |
| Device Name: | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY |
| Classification | System, Breath Measurement |
| Applicant | MICRO DIRECT, INC. 803 WEBSTER ST. Lewiston, ME 04240 |
| Contact | David Staszak |
| Correspondent | David Staszak MICRO DIRECT, INC. 803 WEBSTER ST. Lewiston, ME 04240 |
| Product Code | NRH |
| CFR Regulation Number | 862.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-05-19 |
| Summary: | summary |