The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Ct750 Hd.
| Device ID | K120833 |
| 510k Number | K120833 |
| Device Name: | DISCOVERY CT750 HD |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | John Jaeckle |
| Correspondent | John Jaeckle GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682137553 | K120833 | 000 |
| 00840682125574 | K120833 | 000 |
| 00840682102490 | K120833 | 000 |
| 00195278362247 | K120833 | 000 |
| 00195278362230 | K120833 | 000 |