The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for View Com.
Device ID | K990759 |
510k Number | K990759 |
Device Name: | VIEW COM |
Classification | System, Image Processing, Radiological |
Applicant | ELECTROMED INTL., LTD. 310 INDUSTRIAL BLVD. St-eustache, Quebec, CA J7r 5r4 |
Contact | Pascal M Kaufmann |
Correspondent | Pascal M Kaufmann ELECTROMED INTL., LTD. 310 INDUSTRIAL BLVD. St-eustache, Quebec, CA J7r 5r4 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-08 |
Decision Date | 1999-04-15 |
Summary: | summary |