The following data is part of a premarket notification filed by Leaf Healthcare, Inc. with the FDA for Leaf Patient Monitoring System.
| Device ID | K141877 |
| 510k Number | K141877 |
| Device Name: | LEAF PATIENT MONITORING SYSTEM |
| Classification | Monitor, Bed Patient |
| Applicant | LEAF HEALTHCARE, INC. 755 N MATHILDA AVE. SUITE 100 Sunnyvale, CA 94085 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren LEAF HEALTHCARE, INC. 755 N MATHILDA AVE. SUITE 100 Sunnyvale, CA 94085 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-11 |
| Decision Date | 2014-11-10 |
| Summary: | summary |