The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Ecg Monitor.
| Device ID | K944262 |
| 510k Number | K944262 |
| Device Name: | ECG MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | FUKUDA DENSHI USA, INC. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falf |
| Correspondent | Susan D Goldstein-falf FUKUDA DENSHI USA, INC. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-30 |
| Decision Date | 1995-05-12 |