The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Endomap.
| Device ID | K014113 |
| 510k Number | K014113 |
| Device Name: | ENDOMAP |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Sandra Robinson |
| Correspondent | Sandra Robinson SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-14 |
| Decision Date | 2002-06-14 |
| Summary: | summary |