The following data is part of a premarket notification filed by Maguire Ent., Inc. with the FDA for Ecg Modulator.
| Device ID | K922412 |
| 510k Number | K922412 |
| Device Name: | ECG MODULATOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MAGUIRE ENT., INC. 6289 WEST SUNRISE BLVD., SUITE 115 Fort Lauderdale, FL 33313 |
| Contact | William R Hackett |
| Correspondent | William R Hackett MAGUIRE ENT., INC. 6289 WEST SUNRISE BLVD., SUITE 115 Fort Lauderdale, FL 33313 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1992-07-06 |