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 |