The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Applicard (ekg).
| Device ID | K900459 |
| 510k Number | K900459 |
| Device Name: | APPLICARD (EKG) |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | MEDI-GLOBE CORP. P.O. BOX 18914 Irvine, CA 92713 |
| Contact | Stefan Wohnhas |
| Correspondent | Stefan Wohnhas MEDI-GLOBE CORP. P.O. BOX 18914 Irvine, CA 92713 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-30 |
| Decision Date | 1990-07-31 |