The following data is part of a premarket notification filed by Vocaltech C/o Hogan & Hartson with the FDA for Vocaltech Vocal Feedback Device.
Device ID | K871590 |
510k Number | K871590 |
Device Name: | VOCALTECH VOCAL FEEDBACK DEVICE |
Classification | Device, Anti-stammering |
Applicant | VOCALTECH C/O HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan VOCALTECH C/O HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Product Code | KTH |
CFR Regulation Number | 874.5840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-24 |
Decision Date | 1987-10-06 |