The following data is part of a premarket notification filed by Farrall Instruments, Inc. with the FDA for A Sleep Assessment Device.
Device ID | K792305 |
510k Number | K792305 |
Device Name: | A SLEEP ASSESSMENT DEVICE |
Classification | Device, Sleep Assessment |
Applicant | FARRALL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LEL |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-16 |
Decision Date | 1979-12-20 |