The following data is part of a premarket notification filed by Dymedso Inc. with the FDA for Frequencer, Model 1001.
Device ID | K063645 |
510k Number | K063645 |
Device Name: | FREQUENCER, MODEL 1001 |
Classification | Percussor, Powered-electric |
Applicant | DYMEDSO INC. 127 MAIN ST. Springfield, VT 05156 |
Contact | Jean Bigoney |
Correspondent | Jean Bigoney DYMEDSO INC. 127 MAIN ST. Springfield, VT 05156 |
Product Code | BYI |
CFR Regulation Number | 868.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-07 |
Decision Date | 2007-03-15 |
Summary: | summary |