The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Digaphot Phototherapy Meter Model Pt 145.
Device ID | K780162 |
510k Number | K780162 |
Device Name: | DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 |
Classification | Light, Surgical, Accessories |
Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FTA |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-31 |
Decision Date | 1978-03-27 |