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 |