The following data is part of a premarket notification filed by Heartlab, Inc. with the FDA for Dicomview.
Device ID | K954479 |
510k Number | K954479 |
Device Name: | DICOMVIEW |
Classification | System, Digital Image Communications, Radiological |
Applicant | HEARTLAB, INC. 146 WESTMINSTER ST. SUITE 500 Providence, RI 02903 |
Contact | Richard Petrocelli |
Correspondent | Richard Petrocelli HEARTLAB, INC. 146 WESTMINSTER ST. SUITE 500 Providence, RI 02903 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-26 |
Decision Date | 1996-02-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DICOMVIEW 75046430 2086494 Dead/Cancelled |
HEARTLAB, INC. 1996-01-22 |