The following data is part of a premarket notification filed by Ambulatory Monitoring, Inc. with the FDA for Wrist Actigraph.
| Device ID | K854030 |
| 510k Number | K854030 |
| Device Name: | WRIST ACTIGRAPH |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | AMBULATORY MONITORING, INC. 731 SAW MILL RIVER RD. Ardsley, NY 10502 |
| Contact | William Gruen |
| Correspondent | William Gruen AMBULATORY MONITORING, INC. 731 SAW MILL RIVER RD. Ardsley, NY 10502 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-01 |
| Decision Date | 1986-06-25 |