The following data is part of a premarket notification filed by Grass Instrument Co. with the FDA for Grass Ts3201/6401 Eeg Amplifier System.
| Device ID | K994142 |
| 510k Number | K994142 |
| Device Name: | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | GRASS INSTRUMENT CO. 570 LIBERTY ST. Braintree, MA 02185 |
| Contact | Stephen E Johnson |
| Correspondent | Stephen E Johnson GRASS INSTRUMENT CO. 570 LIBERTY ST. Braintree, MA 02185 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-08 |
| Decision Date | 2000-03-06 |
| Summary: | summary |