The following data is part of a premarket notification filed by Micro Direct, Inc. with the FDA for Microlab Spirometer.
| Device ID | K031102 |
| 510k Number | K031102 |
| Device Name: | MICROLAB SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | MICRO DIRECT, INC. 803 WEBSTER ST. Lewiston, ME 04240 |
| Contact | David R Staszak |
| Correspondent | David R Staszak MICRO DIRECT, INC. 803 WEBSTER ST. Lewiston, ME 04240 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-07 |
| Decision Date | 2003-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54250892905452 | K031102 | 000 |
| 54250892901591 | K031102 | 000 |
| 14250892904341 | K031102 | 000 |
| 14250892904440 | K031102 | 000 |
| 14250892905768 | K031102 | 000 |
| 14250892906635 | K031102 | 000 |
| 14250892906550 | K031102 | 000 |