The following data is part of a premarket notification filed by Vectracor, Inc with the FDA for Vectraplexecg System With Vectraplexami.
| Device ID | K102378 |
| 510k Number | K102378 |
| Device Name: | VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI |
| Classification | Electrocardiograph |
| Applicant | VECTRACOR, INC 169 UNION BLVD Totowa, NJ 07512 |
| Contact | Brad S Schreck |
| Correspondent | Brad S Schreck VECTRACOR, INC 169 UNION BLVD Totowa, NJ 07512 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2011-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857175006029 | K102378 | 000 |