The following data is part of a premarket notification filed by Manufacturing Technology, Inc. with the FDA for Actigraph, Model Am7164-2.2 And Actigraph With Extended Memory, Model Am71256.
| Device ID | K040554 |
| 510k Number | K040554 |
| Device Name: | ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MANUFACTURING TECHNOLOGY, INC. 70 READY AVE., N.W. Fort Walton Beach, FL 32548 |
| Contact | John G Schneider |
| Correspondent | John G Schneider MANUFACTURING TECHNOLOGY, INC. 70 READY AVE., N.W. Fort Walton Beach, FL 32548 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-07-16 |
| Summary: | summary |