The following data is part of a premarket notification filed by Pds Healthcare Products, Inc. with the FDA for Kp + Lfm.
| Device ID | K013489 |
| 510k Number | K013489 |
| Device Name: | KP + LFM |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | PDS HEALTHCARE PRODUCTS, INC. 908 MAIN ST. Louisville, CO 80027 |
| Contact | Jim Lewis |
| Correspondent | Jim Lewis PDS HEALTHCARE PRODUCTS, INC. 908 MAIN ST. Louisville, CO 80027 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2001-11-29 |
| Summary: | summary |