The following data is part of a premarket notification filed by Tactilitics, Inc. with the FDA for Rsvp Systems, Series I, Bed-patient Monitor.
Device ID | K864827 |
510k Number | K864827 |
Device Name: | RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR |
Classification | Monitor, Bed Patient |
Applicant | TACTILITICS, INC. 1021 PEARL ST. Boulder, CO 80302 |
Contact | George Beggs |
Correspondent | George Beggs TACTILITICS, INC. 1021 PEARL ST. Boulder, CO 80302 |
Product Code | KMI |
CFR Regulation Number | 880.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-09 |
Decision Date | 1987-01-21 |