The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Amplifier Otrona, Model N3a-emg.
| Device ID | K772102 |
| 510k Number | K772102 |
| Device Name: | AMPLIFIER OTRONA, MODEL N3A-EMG |
| Classification | Amplifier, Physiological Signal |
| Applicant | HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-07 |
| Decision Date | 1977-11-21 |