The following data is part of a premarket notification filed by Almicro Electronics, Inc. with the FDA for Apello, Personal Health Support Sys..
Device ID | K831093 |
510k Number | K831093 |
Device Name: | APELLO, PERSONAL HEALTH SUPPORT SYS. |
Classification | System, Communication, Powered |
Applicant | ALMICRO ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ILQ |
CFR Regulation Number | 890.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-04 |
Decision Date | 1983-05-16 |