The following data is part of a premarket notification filed by Healthscan Products, Inc. with the FDA for Personal Best Ii With Zone Management System.
| Device ID | K962924 |
| 510k Number | K962924 |
| Device Name: | PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM |
| 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 | 1996-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730004563 | K962924 | 000 |
| 00383730004648 | K962924 | 000 |
| 00383730004617 | K962924 | 000 |
| 50885403174825 | K962924 | 000 |