The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Etg-100 Optical Encephalography System.
| Device ID | K011320 |
| 510k Number | K011320 |
| Device Name: | ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM |
| Classification | Oximeter |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Robert H Mccarthy |
| Correspondent | Robert H Mccarthy HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-01 |
| Decision Date | 2001-08-09 |