The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Intrabeam 600.
| Device ID | K162568 |
| 510k Number | K162568 |
| Device Name: | INTRABEAM 600 |
| Classification | System, Therapeutic, X-ray |
| Applicant | CARL ZEISS MEDITEC AG GOESCHWITZER STR. 51-52 Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Calley Herzog Biologics Consulting 400 N. Washington St. Suite 100 Alexandria, VA 22314 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-14 |
| Decision Date | 2016-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539064059 | K162568 | 000 |