The following data is part of a premarket notification filed by Biohm, Inc. with the FDA for Dad 16s, Data Acquistion Device 16 Ch. Series.
| Device ID | K883461 |
| 510k Number | K883461 |
| Device Name: | DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES |
| Classification | Encephalogram Telemetry System |
| Applicant | BIOHM, INC. 1050 WALNUT ST. STE.205 Boulder, CO 80302 |
| Contact | Miller, Md |
| Correspondent | Miller, Md BIOHM, INC. 1050 WALNUT ST. STE.205 Boulder, CO 80302 |
| Product Code | GYE |
| CFR Regulation Number | 882.1855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-12 |
| Decision Date | 1988-11-30 |