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 |