The following data is part of a premarket notification filed by Vectracor, Inc. with the FDA for Universal Smartecg.
Device ID | K173952 |
510k Number | K173952 |
Device Name: | Universal SmartECG |
Classification | Electrocardiograph |
Applicant | VectraCor, Inc. 785 Totowa Rd. Suite 100 Totowa, NJ 07512 |
Contact | Andrew Schreck |
Correspondent | Andrew Schreck VectraCor, Inc. 785 Totowa Rd. Suite 100 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 | 2017-12-27 |
Decision Date | 2018-08-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857175006173 | K173952 | 000 |