The following data is part of a premarket notification filed by Ep Technologies, Inc. with the FDA for Astronomer Plus System.
| Device ID | K013349 |
| 510k Number | K013349 |
| Device Name: | ASTRONOMER PLUS SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | EP TECHNOLOGIES, INC. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Andrea L Ruth |
| Correspondent | Andrea L Ruth EP TECHNOLOGIES, INC. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-09 |
| Decision Date | 2002-04-09 |
| Summary: | summary |