The following data is part of a premarket notification filed by Ferraris Respiratory, Inc. with the FDA for Koko Spirometer.
| Device ID | K914272 |
| 510k Number | K914272 |
| Device Name: | KOKO SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | FERRARIS RESPIRATORY, INC. P.O. BOX 400 Louisville, CO 80027 |
| Contact | Arlin Lehman |
| Correspondent | Arlin Lehman FERRARIS RESPIRATORY, INC. P.O. BOX 400 Louisville, CO 80027 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-24 |
| Decision Date | 1992-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852417003347 | K914272 | 000 |
| 00852417003316 | K914272 | 000 |