The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Intergrated Monitoring Archiving And Communications Systems (imacs).
| Device ID | K941762 |
| 510k Number | K941762 |
| Device Name: | INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-11 |
| Decision Date | 1995-02-22 |