The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Flochannel.
| Device ID | K081176 |
| 510k Number | K081176 |
| Device Name: | FLOCHANNEL |
| Classification | Ventilatory Effort Recorder |
| Applicant | CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
| Contact | Kevin Mcculloh |
| Correspondent | Kevin Mcculloh CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-25 |
| Decision Date | 2008-07-28 |
| Summary: | summary |