The following data is part of a premarket notification filed by Senior Technologies, Inc. with the FDA for Senior Tech Tabs 88 Trans Ra1/wra1/r1 Ann Type Cr1.
Device ID | K924433 |
510k Number | K924433 |
Device Name: | SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 |
Classification | Monitor, Bed Patient |
Applicant | SENIOR TECHNOLOGIES, INC. P.O. BOX 80238 Lincoln, NE 68501 -0238 |
Contact | Balters |
Correspondent | Balters SENIOR TECHNOLOGIES, INC. P.O. BOX 80238 Lincoln, NE 68501 -0238 |
Product Code | KMI |
CFR Regulation Number | 880.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-01 |
Decision Date | 1993-06-24 |