The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Peak Expiratory Flow Meter.
| Device ID | K912866 |
| 510k Number | K912866 |
| Device Name: | PEAK EXPIRATORY FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | HEALTH PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 |
| Contact | Lauren R Ziegler |
| Correspondent | Lauren R Ziegler HEALTH PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-28 |
| Decision Date | 1992-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730000619 | K912866 | 000 |
| 00383730000442 | K912866 | 000 |
| 00383730000435 | K912866 | 000 |
| 00383730000428 | K912866 | 000 |
| 00383730000411 | K912866 | 000 |
| 00383730000404 | K912866 | 000 |
| 00383730000398 | K912866 | 000 |