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 |