The following data is part of a premarket notification filed by Sphygmetrics, Inc. with the FDA for Infrasonde Auto/inflator Elec. Vibrator.
Device ID | K800179 |
510k Number | K800179 |
Device Name: | INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR |
Classification | System, Phonocatheter, Intracavitary |
Applicant | SPHYGMETRICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXW |
CFR Regulation Number | 870.1270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-29 |
Decision Date | 1980-02-11 |