The following data is part of a premarket notification filed by Micro Direct, Inc. with the FDA for Micro H2.
| Device ID | K963376 |
| 510k Number | K963376 |
| Device Name: | MICRO H2 |
| Classification | System, Breath Measurement |
| Applicant | MICRO DIRECT, INC. P.O. BOX 239 840 POWNAL ROAD Auburn, ME 04210 -0239 |
| Contact | David Staszak |
| Correspondent | David Staszak MICRO DIRECT, INC. P.O. BOX 239 840 POWNAL ROAD Auburn, ME 04210 -0239 |
| Product Code | NRH |
| CFR Regulation Number | 862.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1997-01-24 |