The following data is part of a premarket notification filed by Medtechs, Llc with the FDA for Ansha Autonomic Nervous System Health Assessment Plus.
| Device ID | K083735 |
| 510k Number | K083735 |
| Device Name: | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | MEDTECHS, LLC 111 BEAVER DAM RUN Durhan, NC 27703 |
| Contact | Meghan Ath |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-16 |
| Decision Date | 2009-02-18 |
| Summary: | summary |