The following data is part of a premarket notification filed by Ferraris Medical, Inc. with the FDA for Wright Pocket Peak Flow Meter.
Device ID | K924343 |
510k Number | K924343 |
Device Name: | WRIGHT POCKET PEAK FLOW METER |
Classification | Meter, Peak Flow, Spirometry |
Applicant | FERRARIS MEDICAL, INC. P.O. BOX 344 Holland, NY 14080 |
Contact | David R Malys |
Correspondent | David R Malys FERRARIS MEDICAL, INC. P.O. BOX 344 Holland, NY 14080 |
Product Code | BZH |
CFR Regulation Number | 868.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-27 |
Decision Date | 1993-06-16 |