The following data is part of a premarket notification filed by Tactilitics, Inc. with the FDA for Rsvp Rf-2000.
Device ID | K905586 |
510k Number | K905586 |
Device Name: | RSVP RF-2000 |
Classification | Monitor, Bed Patient |
Applicant | TACTILITICS, INC. 5595 ARAPAHOE Boulder, CO 80303 |
Contact | Katherine Hutman |
Correspondent | Katherine Hutman TACTILITICS, INC. 5595 ARAPAHOE Boulder, CO 80303 |
Product Code | KMI |
CFR Regulation Number | 880.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-06 |
Decision Date | 1991-04-01 |