The following data is part of a premarket notification filed by Pds Healthcare Products, Inc. with the FDA for Koko Peak Kp; Koko Peak Kp+.
| Device ID | K010009 |
| 510k Number | K010009 |
| Device Name: | KOKO PEAK KP; KOKO PEAK KP+ |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | PDS HEALTHCARE PRODUCTS, INC. 908 MAIN ST. Louisvile, CO 80027 |
| Contact | Cheryl Railsback |
| Correspondent | Cheryl Railsback PDS HEALTHCARE PRODUCTS, INC. 908 MAIN ST. Louisvile, CO 80027 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-02 |
| Decision Date | 2001-06-01 |