The following data is part of a premarket notification filed by Henry Ford Hospital with the FDA for Non-invasive Amplifier.
Device ID | K810828 |
510k Number | K810828 |
Device Name: | NON-INVASIVE AMPLIFIER |
Classification | Amplifier And Signal Conditioner, Biopotential |
Applicant | HENRY FORD HOSPITAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRR |
CFR Regulation Number | 870.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-24 |
Decision Date | 1981-04-10 |