The following data is part of a premarket notification filed by Micro Direct, Inc. with the FDA for Micropeak.
| Device ID | K030586 |
| 510k Number | K030586 |
| Device Name: | MICROPEAK |
| Classification | Meter, Peak Flow, Spirometry |
| 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 | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-24 |
| Decision Date | 2003-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34250892980172 | K030586 | 000 |
| 34250892980165 | K030586 | 000 |
| 34250892904475 | K030586 | 000 |
| 34250892904468 | K030586 | 000 |
| 34250892901535 | K030586 | 000 |
| 34250892901528 | K030586 | 000 |