The following data is part of a premarket notification filed by Imtech Corp. with the FDA for Carbocone.
Device ID | K851732 |
510k Number | K851732 |
Device Name: | CARBOCONE |
Classification | Electrode, Electrocardiograph |
Applicant | IMTECH CORP. 260 WEST BROADWAY New York, NY 10013 |
Contact | Paul Noble |
Correspondent | Paul Noble IMTECH CORP. 260 WEST BROADWAY New York, NY 10013 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARBOCONE 73562361 1400236 Live/Registered |
REMATRA RESEARCH, MARKETING AND TRADINGCOMPANY, SA 1985-10-09 |