The following data is part of a premarket notification filed by Ndm Acquisition Corp. with the FDA for Ndm Silvon Ecg Electrodes.
| Device ID | K931457 |
| 510k Number | K931457 |
| Device Name: | NDM SILVON ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | NDM ACQUISITION CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Contact | Donald Koopman |
| Correspondent | Donald Koopman NDM ACQUISITION CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-23 |
| Decision Date | 1993-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816310022997 | K931457 | 000 |