The following data is part of a premarket notification filed by Sorensen Research with the FDA for Disposable Diaphragm Done.
Device ID | K803011 |
510k Number | K803011 |
Device Name: | DISPOSABLE DIAPHRAGM DONE |
Classification | Amplifier And Signal Conditioner, Transducer Signal |
Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRQ |
CFR Regulation Number | 870.2060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-28 |
Decision Date | 1980-12-31 |