The following data is part of a premarket notification filed by Actegy Ltd with the FDA for Aerosure Medic.
| Device ID | K140772 |
| 510k Number | K140772 |
| Device Name: | AEROSURE MEDIC |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Actegy Ltd 555 13TH STREET, NW Washington, DC 20004 |
| Contact | John J Smith, M.d., J.d. |
| Correspondent | John J Smith, M.d., J.d. HOGAN LOVELLS US LLP 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-27 |
| Decision Date | 2014-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858058005044 | K140772 | 000 |