The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies Gmbh with the FDA for Responder 3000.
| Device ID | K000638 |
| 510k Number | K000638 |
| Device Name: | RESPONDER 3000 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH MUNZINGER STR. 3 Freiburg, DE 79111 |
| Contact | Klaus Rudolf |
| Correspondent | Klaus Rudolf GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH MUNZINGER STR. 3 Freiburg, DE 79111 |
| Product Code | MKJ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-10-30 |