The following data is part of a premarket notification filed by Healthscan Products, Inc. with the FDA for Personal Best Ii.
Device ID | K962929 |
510k Number | K962929 |
Device Name: | PERSONAL BEST II |
Classification | Meter, Peak Flow, Spirometry |
Applicant | HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292 |
Contact | Lauren R Ziegler |
Correspondent | Lauren R Ziegler HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292 |
Product Code | BZH |
CFR Regulation Number | 868.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-29 |
Decision Date | 1996-10-24 |