The following data is part of a premarket notification filed by Stasis Labs, Inc. with the FDA for Stasis Monitoring System.
| Device ID | K183634 |
| 510k Number | K183634 |
| Device Name: | Stasis Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Stasis Labs, Inc. 9121 Airdrome St. Los Angeles, CA 90035 |
| Contact | Derek Nielsen |
| Correspondent | Eric Eggers 510konsult LLC 754 NW Broadway, Suite 206 Bend, OR 97703 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854271008001 | K183634 | 000 |