The following data is part of a premarket notification filed by Hhssystems, Llc with the FDA for Qans (quantitative Autonomic Nervous System) Monitoring System.
| Device ID | K142551 |
| 510k Number | K142551 |
| Device Name: | QANS (Quantitative Autonomic Nervous System) Monitoring System |
| Classification | Electrocardiograph |
| Applicant | HHSsystems, LLC 2 Executive Blvd., Suite 206 Suffern, NY 10901 |
| Contact | Howard G. Hindin |
| Correspondent | Jane B. Campbell Campbell Associates 164 Hammock Avenue Pawleys, SC 29585 |
| Product Code | DPS |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | KZM |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-10 |
| Decision Date | 2015-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001651904 | K142551 | 000 |
| 00860001651911 | K142551 | 000 |