The following data is part of a premarket notification filed by Healthscan Products, Inc. with the FDA for Personal Best Low Range.
| Device ID | K933889 |
| 510k Number | K933889 |
| Device Name: | PERSONAL BEST LOW RANGE |
| 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 | 1993-08-10 |
| Decision Date | 1993-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730000480 | K933889 | 000 |
| 00383730000473 | K933889 | 000 |
| 00383730000466 | K933889 | 000 |
| 00383730000459 | K933889 | 000 |