The following data is part of a premarket notification filed by Reeves Scientific, Inc. with the FDA for Dynamic Spectral Phonocardiograph.
Device ID | K902185 |
510k Number | K902185 |
Device Name: | DYNAMIC SPECTRAL PHONOCARDIOGRAPH |
Classification | Phonocardiograph |
Applicant | REEVES SCIENTIFIC, INC. 65 NASH ST. New Haven, CT 06511 |
Contact | William Reeves |
Correspondent | William Reeves REEVES SCIENTIFIC, INC. 65 NASH ST. New Haven, CT 06511 |
Product Code | DQC |
CFR Regulation Number | 870.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-14 |
Decision Date | 1991-03-25 |