The following data is part of a premarket notification filed by Medchannel, Llc with the FDA for Medchannel Hts System.
| Device ID | K061831 |
| 510k Number | K061831 |
| Device Name: | MEDCHANNEL HTS SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDCHANNEL, LLC 55 WORCESTER STREET, #3 Boston, MA 02118 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia MEDCHANNEL, LLC 55 WORCESTER STREET, #3 Boston, MA 02118 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-28 |
| Decision Date | 2006-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EAMIRAR20810 | K061831 | 000 |
| EAMIRAR20110 | K061831 | 000 |
| EAMIAHE2030 | K061831 | 000 |
| EAMIAHA0030 | K061831 | 000 |
| EAMIAHH0010 | K061831 | 000 |