The following data is part of a premarket notification filed by Zyter, Inc. with the FDA for Zyter Rpm.
| Device ID | K212622 |
| 510k Number | K212622 |
| Device Name: | Zyter RPM |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Zyter, Inc. 2600 Tower Oaks Blvd. Suite 700 Rockville, MD 20852 |
| Contact | Lakshmi Narayana Babu |
| Correspondent | Mary Vater Medical Device Academy, Inc 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-02-11 |