The following data is part of a premarket notification filed by Pulmonary Data Services, Inc. with the FDA for Koko Legend.
| Device ID | K051572 |
| 510k Number | K051572 |
| Device Name: | KOKO LEGEND |
| Classification | Spirometer, Diagnostic |
| Applicant | PULMONARY DATA SERVICES, INC. 908 MAIN STREET Louisville, CO 80027 |
| Contact | Donald Henton |
| Correspondent | Donald Henton PULMONARY DATA SERVICES, INC. 908 MAIN STREET Louisville, CO 80027 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-14 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852417003361 | K051572 | 000 |
| 00852417003354 | K051572 | 000 |