The following data is part of a premarket notification filed by Innovative Medical Solutions, Inc. with the FDA for Tel-echo System.
Device ID | K990052 |
510k Number | K990052 |
Device Name: | TEL-ECHO SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | INNOVATIVE MEDICAL SOLUTIONS, INC. 1250 NEWPORT DR. Oconomowoc, WI 53066 |
Contact | Lawrence E Sieb,jr |
Correspondent | Lawrence E Sieb,jr INNOVATIVE MEDICAL SOLUTIONS, INC. 1250 NEWPORT DR. Oconomowoc, WI 53066 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-07 |
Decision Date | 1999-02-19 |
Summary: | summary |