The following data is part of a premarket notification filed by Caldyne, Inc. with the FDA for Caldyne, Inc. Exhalometer Ex100, Model Ex100.
Device ID | K051279 |
510k Number | K051279 |
Device Name: | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 |
Classification | Spirometer, Monitoring (w/wo Alarm) |
Applicant | CALDYNE, INC. 29201 VIA NORTE Temecula, CA 92591 |
Contact | Tom Shanks |
Correspondent | Tom Shanks CALDYNE, INC. 29201 VIA NORTE Temecula, CA 92591 |
Product Code | BZK |
CFR Regulation Number | 868.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-17 |
Decision Date | 2005-09-07 |
Summary: | summary |