The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Dimension Vista Digitoxin Calibrator - Dgtx Cal.
| Device ID | K103360 |
| 510k Number | K103360 |
| Device Name: | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL |
| Classification | Calibrator, Secondary |
| Applicant | SIEMENS CORP. 500 GBC DRIVE MAILSTOP 514 P.O. BOX 6101 Newark, DE 19714 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS CORP. 500 GBC DRIVE MAILSTOP 514 P.O. BOX 6101 Newark, DE 19714 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2010-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768033322 | K103360 | 000 |