The following data is part of a premarket notification filed by Palo Alto Health Sciences, Inc. with the FDA for Cancary Breathing System.
| Device ID | K131586 |
| 510k Number | K131586 |
| Device Name: | CANCARY BREATHING SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | PALO ALTO HEALTH SCIENCES, INC. 755 N MATHILDA AVE SUITE 100 Sunnyvale, CA 94085 |
| Contact | Lori Adels, Phd |
| Correspondent | Lori Adels, Phd PALO ALTO HEALTH SCIENCES, INC. 755 N MATHILDA AVE SUITE 100 Sunnyvale, CA 94085 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B185SM40500 | K131586 | 000 |