The following data is part of a premarket notification filed by Bennett And Assoc., Inc. with the FDA for Spectradop.
Device ID | K925078 |
510k Number | K925078 |
Device Name: | SPECTRADOP |
Classification | Transducer, Ultrasonic |
Applicant | BENNETT AND ASSOC., INC. 67079 READ RD. Cambridge, OH 43725 |
Contact | John B Bennett |
Correspondent | John B Bennett BENNETT AND ASSOC., INC. 67079 READ RD. Cambridge, OH 43725 |
Product Code | JOP |
Subsequent Product Code | DSB |
Subsequent Product Code | JOM |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-07 |
Decision Date | 1995-07-17 |