The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Cardiolight.
Device ID | K982448 |
510k Number | K982448 |
Device Name: | CARDIOLIGHT |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Contact | Mary Anne Dell |
Correspondent | Mary Anne Dell CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-15 |
Decision Date | 1999-06-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARDIOLIGHT 86171263 not registered Dead/Abandoned |
Edward Chen 2014-01-21 |
CARDIOLIGHT 75249681 not registered Dead/Abandoned |
Vista Medical Technologies, Inc. 1997-02-28 |