The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Aw Server.
| Device ID | K081985 |
| 510k Number | K081985 |
| Device Name: | AW SERVER |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. W706 Waukesha, WI 53188 |
| Contact | Stephen Slavens |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102384 | K081985 | 000 |