The following data is part of a premarket notification filed by Human Technologies, Inc. with the FDA for Bed Patient Presence Monitor.
Device ID | K871203 |
510k Number | K871203 |
Device Name: | BED PATIENT PRESENCE MONITOR |
Classification | Monitor, Bed Patient |
Applicant | HUMAN TECHNOLOGIES, INC. 1325 SNELL ISLE BLVD N.E. St. Petersburg, FL 33704 |
Contact | Michael Hazel |
Correspondent | Michael Hazel HUMAN TECHNOLOGIES, INC. 1325 SNELL ISLE BLVD N.E. St. Petersburg, FL 33704 |
Product Code | KMI |
CFR Regulation Number | 880.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-25 |
Decision Date | 1987-05-26 |