The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Flow Spirometer.
Device ID | K934502 |
510k Number | K934502 |
Device Name: | FLOW SPIROMETER |
Classification | Meter, Peak Flow, Spirometry |
Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
Contact | Tim Cowart |
Correspondent | Tim Cowart HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
Product Code | BZH |
CFR Regulation Number | 868.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-14 |
Decision Date | 1994-04-04 |