The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Photoflo Dual-mode Photoplethysmograph.
Device ID | K832374 |
510k Number | K832374 |
Device Name: | PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH |
Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
Applicant | SONICAID, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOM |
CFR Regulation Number | 870.2780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-18 |
Decision Date | 1983-12-01 |