The following data is part of a premarket notification filed by Cybermedic, Inc. with the FDA for Pff-1.
| Device ID | K914205 |
| 510k Number | K914205 |
| Device Name: | PFF-1 |
| Classification | Spirometer, Diagnostic |
| Applicant | CYBERMEDIC, INC. C/O MCKENNA & CUNEO LAW OFFICE 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard D Manthei |
| Correspondent | Richard D Manthei CYBERMEDIC, INC. C/O MCKENNA & CUNEO LAW OFFICE 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-19 |
| Decision Date | 1992-05-01 |