The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Cardiopal Ai With Diogenes Sv (cardiopal Sv), Model Pm410.
| Device ID | K043454 |
| 510k Number | K043454 |
| Device Name: | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | MEDICOMP, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MEDICOMP, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-15 |
| Decision Date | 2005-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862887000340 | K043454 | 000 |