The following data is part of a premarket notification filed by Grass Instrument Co. with the FDA for Grass-telefactor As40 Amplifier System.
| Device ID | K021807 |
| 510k Number | K021807 |
| Device Name: | GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | GRASS INSTRUMENT CO. 570 LIBERTY ST. Braintree, MA 02185 |
| Contact | Peter L Fuller |
| Correspondent | Peter L Fuller 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 | 2002-06-03 |
| Decision Date | 2002-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830028660 | K021807 | 000 |