The following data is part of a premarket notification filed by Flowscan, Inc. with the FDA for Life Sound Sensor.
Device ID | K952651 |
510k Number | K952651 |
Device Name: | LIFE SOUND SENSOR |
Classification | Phonocardiograph |
Applicant | FLOWSCAN, INC. 75 CASTENADA AVE. San Francisco, CA 94116 -1406 |
Contact | Robert L Lofts |
Correspondent | Robert L Lofts FLOWSCAN, INC. 75 CASTENADA AVE. San Francisco, CA 94116 -1406 |
Product Code | DQC |
CFR Regulation Number | 870.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-09 |
Decision Date | 1995-09-19 |