The following data is part of a premarket notification filed by Micro Direct, Inc. with the FDA for Micro Spirometer.
| Device ID | K963035 |
| 510k Number | K963035 |
| Device Name: | MICRO SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | MICRO DIRECT, INC. 840 POWNAL RD. Auburn, ME 04210 |
| Contact | David R Staszak |
| Correspondent | David R Staszak MICRO DIRECT, INC. 840 POWNAL RD. Auburn, ME 04210 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-11-01 |
| Summary: | summary |