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 |