The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Digoxin Calibrators.
| Device ID | K972433 |
| 510k Number | K972433 |
| Device Name: | CEDIA DIGOXIN CALIBRATORS |
| Classification | Calibrators, Drug Specific |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-07-24 |
| Summary: | summary |