The following data is part of a premarket notification filed by Micro Direct, Inc. with the FDA for Micro Mpm.
| Device ID | K940375 |
| 510k Number | K940375 |
| Device Name: | MICRO MPM |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | MICRO DIRECT, INC. 120 CENTER ST. #105 Auburn, ME 04210 |
| Contact | David R Staszak |
| Correspondent | David R Staszak MICRO DIRECT, INC. 120 CENTER ST. #105 Auburn, ME 04210 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-26 |
| Decision Date | 1994-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54250892905490 | K940375 | 000 |
| 14250892903870 | K940375 | 000 |
| 14250892904082 | K940375 | 000 |
| 14250892904105 | K940375 | 000 |
| 14250892904112 | K940375 | 000 |
| 14250892901715 | K940375 | 000 |
| 14250892901777 | K940375 | 000 |
| 14250892902040 | K940375 | 000 |
| 14250892903801 | K940375 | 000 |
| 14250892903818 | K940375 | 000 |
| 54250892901546 | K940375 | 000 |
| 14250892905775 | K940375 | 000 |