The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Modified Assess(r) Peak Flow Meter.
| Device ID | K896953 |
| 510k Number | K896953 |
| Device Name: | MODIFIED ASSESS(R) PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | HEALTH PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 |
| Contact | Frank J Alvino |
| Correspondent | Frank J Alvino 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 | 1989-12-05 |
| Decision Date | 1990-01-30 |