The following data is part of a premarket notification filed by Skidmore Medical, Limited with the FDA for Studiodop Vicorder.
Device ID | K071730 |
510k Number | K071730 |
Device Name: | STUDIODOP VICORDER |
Classification | Transducer, Ultrasonic |
Applicant | SKIDMORE MEDICAL, LIMITED 7744 SWAPS TRAIL Evergreen, CO 80439 -6310 |
Contact | David W Wagner |
Correspondent | David W Wagner SKIDMORE MEDICAL, LIMITED 7744 SWAPS TRAIL Evergreen, CO 80439 -6310 |
Product Code | JOP |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-25 |
Decision Date | 2007-12-20 |